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   Table of Contents - Current issue
Coverpage
July-December 2017
Volume 38 | Issue 3 & 4
Page Nos. 95-178

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EDITORIAL  

Need of systematic review of clinical trials in Ayurveda Highly accessed article p. 95
Mandip Goyal
DOI:10.4103/ayu.AYU_115_18  
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REVIEW ARTICLES Top

Critical review on Samyoga Viruddha (combination incompatibility) with special emphasis on carcinogenic effect of combination of betel quid, areca nut and tobacco Highly accessed article p. 97
Malhari K Sirdeshpande, Vidyadhish Anantrao Kashikar
DOI:10.4103/ayu.AYU_71_16  
Background: The system of ancient Indian medicine is contributing in the global health since the time immemorial. Fast food and different types of addictions like tobacco etc. are becoming part of new lifestyles. Concept of Viruddha (hostility) is one such principle under the umbrella of which many such newly adopted faulty and harmful lifestyle combination could be placed. Samyoga Viruddha (combination incompatibility) is the term used to denote unwholesome effects of two or more combined things. Tobacco preparations or other addictions coming under the concept of Samyoga Viruddha may not show any hazardous effects initially due to Vitathatwa (futility). Vamana (therapeutic vomiting), Virechana (therapeutic purgation), Samshamana (intervention to normalize vitiated body constituents and function), Samskara (pharmaceutical processing of a drug) and Padamshika Krama (gradual adoption and quitting) are some measures to deal with disorders produced by Samyoga Viruddha.Aims and Objectives: This article is aimed to elaborate the concept of Samyoga and Samyoga Viruddha with special emphasis on tobacco as an example. Materials and Methods: Data are collected from ancient texts and recent research articles, supported with discussion and presented. Results: Article concludes that betel quid, which is a mixture of areca nut, betel leaf, slaked lime and tobacco is a perfect example of Samyoga Viruddha and its hazardous effects can be managed with principles of Viruddha Ahara (mutually contraindicated food).
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Quality of life improvement with rehabilitation according to constitution of the World Health Organization for coronary artery bypass graft surgery patients: A descriptive review p. 102
Amaravathi Eraballi, Balaram Pradhan
DOI:10.4103/ayu.AYU_152_17  
This is a descriptive review focusing on trends of treatments required for postoperative coronary artery bypass graft surgery (CABG) patients to improve the quality of life (QOL). Methodology: The sources of literary research to understand the concepts of coronary artery disease according to Indian scriptures are Ayurveda texts, Bhagavad Gita, Patanjali Yoga Sutra. The data was typed in Sanskrit using Devanagari script and explanation in English was given. As per new research techniques, surgery, physiotherapy rehabilitation and Yoga are serving CABG patient's medical and psychological health better. The World Health Organization (WHO) defines health as physical, mental and social well-being later redefined with additional terms like environmental and spiritual health. This definition is similar to the Panchakosha concept in Yoga and Pancha Mahabhutas in Ayurveda. In cases of emergency or passive treatment, medication serves as a better option for physical health. In circumstances where the person is able to move in daily activities (just after discharge), rehabilitation serves as a better option for physical, mental and social health. Travel and reactions to climatic change serve environmental health. Last strategy, belief, cultural and traditional methods with scientific background serves as the spiritual health. These step-wise treatments are required for CABG patients to get the overall health or QOL. However, surgery and physiotherapy rehabilitation are advanced as per modern era which serves physical, mental, and social health also, but environmental health and spiritual health have yet to be addressed. As an ancient system of medicine, Yoga combines physical, mental, social, environmental and spiritual practices and it should be added as treatment along with surgery and physiotherapy rehabilitation. If all of these therapies were in the treatment protocol for CABG surgery patients, we would observe the changes of QOL and fulfill the requirements of constitution of the WHO. Integrating concepts of Yoga, Ayurveda, modern rehabilitation, surgery and patient cooperation with lifestyle change are the key to QOL improvements after CABG.
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ORIGINAL ARTICLES Top

Changes in functional magnetic resonance imaging with Yogic meditation: A pilot study p. 108
Shri K Mishra, Shaweta Khosa, Sandeep Singh, Negar Moheb, Bhavesh Trikamji
DOI:10.4103/ayu.AYU_34_17  
Background: The neural substrates of Yogic meditation are not well understood. Meditation is theorized to be a conscious mental process that induces a set of complex physiological changes within the areas of the brain termed as the “relaxation response.” Aims and objective: Pilot data of a functional magnetic resonance imaging (fMRI) study is presented to observe and understand the selective activations of designated brain regions during meditation. Material and methods: Four trained healthy Patanjali Yoga practitioners in their mid-60s participated in this prototype interventional study. A three-part 1-min block design alternating between meditation (test) and relaxation (control) phase with an imaginary visual fixation and auditory stimulation was used. Result and observation: The fMRI images revealed strong activation in the right prefrontal regions during the visual and auditory fixation meditation phases compared to no activations during the relaxation phase. A comparison between the visual and auditory fixations revealed shifts within the prefrontal and temporal regions. In addition, activation in occipital and temporal regions was observed during the meditation phase. Occipital lobe activation was more apparent during visual meditation phase. Conclusion: It is concluded that specific fMRI brain activations are observed during different forms of Yogic meditation (visual and auditory phases). Occipital and prefrontal activation could be modulating the known neurophysiological and biological effects of meditation.
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Wipeout period of spinal anesthesia in hemorrhoidectomy in relation to Prakriti: An observational study p. 113
Pradeep S Shindhe, Sudheer Kumar Pandey, Ramesh Killedar
DOI:10.4103/ayu.AYU_43_17  
Background: A maximum number of hemorrhoidectomies are performed under spinal anesthesia. However, the effect of spinal anesthesia varies from person to person due to difference in their physical and psychological properties, which is well explained in Ayurveda as Prakriti (physiology of an individual). In this study, we have tried to establish a relation between wipeout period of spinal anesthesia and different Prakriti. Objectives: To observe wipeout period of spinal anesthesia in hemorrhoidectomy in relation to different Prakriti. Materials and Methods: A total of 30 individuals who underwent hemorrhoidectomy under spinal anesthesia were selected for the study and their Prakriti was assessed as per the standard Prakriti assessment chart before surgery. Apart from demographic data, pain assessment was also recorded by following visual analog scale. Postoperative follow-up was done until the wipeout effect of spinal anesthesia was observed. GraphPad Prism software was used to analyze the data; P < 0.05 was considered statistically significant. Results: Male predominance was observed in hemorrhoidectomy cases. Majority of the patients were 20–25 years of age with body weight between 61 and 70 kg. Distribution of Prakriti was observed to be highest in Vata-Pitta Prakriti (36.6%). A significant difference was observed in the wipeout period among Prakriti where the duration of wipeout period was more in the Kapha Prakriti individuals (P < 0.0001). Conclusion: Kapha involvement increases the wipeout period in posthemorrhoidectomy; however, in Pitta and Vata Prakriti individuals, the wipeout period is less. Future studies could include a larger sample size and various other factors to analyze the involvement of Kapha.
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Evaluation of anti-inflammatory effects of systemically administered curcumin, lycopene and piperine as an adjunct to scaling and root planing: A clinical study p. 117
Supreet Kaur, Richa Sharma, Vandana Sarangal, Navkiran Kaur, Pallavi Prashar
DOI:10.4103/ayu.AYU_63_17  
Background: The natural herbal extracts curcumin (Curcuma longa), lycopene and piperine demonstrated a very potent anti-inflammatory action and can be used as an antioxidant therapy in the management of inflammatory processes such as gingivitis and periodontitis. Aim and Objective: The aim of the present study is to evaluate the effects of systemically administered extracts curcumin, lycopene and piperine as an adjunct to scaling and root planing (SRP) in patients with moderate gingivitis. Materials and Methods: Sixty systemically healthy participants with moderate gingivitis were enrolled in a randomized clinical study. Participants were randomly distributed into two treatment groups: Group I (test group) (350 mg/day antioxidant therapy) along with SRP for 3 weeks and Group II (control group) SRP alone. Clinical parameters such as plaque index, gingival index and probing pocket depth were evaluated at baseline and after 21 days using paired t-test. Results: Both the treatment groups showed statistically significant reduction in clinical parameters, but the test group showed greater reduction as compared to control group (P < 0.05). Conclusion: The results concluded that systemically administered antioxidants could cause better resolution of inflammation when used as an adjunct to SRP.
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Comparative clinical study of Apamarga Kshara application, infrared coagulation and Arshohara Vati in the management of Arsha (1st and 2nd degree hemorrhoids) p. 122
Komang Sudarmi, Tukaram Sambhaji Dudhamal
DOI:10.4103/ayu.AYU_94_17  
Introduction: In anorectal disorders, incidences of piles and fissures are increasing in Indian population due to western lifestyle. Many surgical methods are available to cure anorectal disorders, but now a days, demand for Ayurveda and herbal preparation is increasing in society. Materials and Methods: In this study, Apamarga Kshara application, infrared coagulation (IRC) procedure and Arshohara Vati (AV) tablet were administered for the management of internal hemorrhoid (Arsha). This study was an open labelled, prospective, interventional study, in which patients of piles [n = 30 (10 each group)] were selected from OPD of Institutional hospital. Apamarga Kshara application (AKA) was done on the internal piles for 1–3 sittings as per requirement, IRC was applied at the base of piles for one sitting and two tablets (500 mg each tablet) of AV were given orally thrice a day for 15 days. In all the three groups, the patients were assessed every week for 1 month and were followed up for another 1 month for relief in signs and symptoms. Results: Obtained results were analyzed and encouraging results were observed after completion of the treatment. Conclusion: The study concluded that Apamarga Kshara application is the most effective treatment for the management of internal hemorrhoid of 1st and 2nd degree in comparison to IRC procedure and administration of Arshohara Vati.
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Clinical efficacy of Vamana Karma with Ikshwaaku Beeja Yoga followed by Shatapushpadi Ghanavati in the management of Artava Kshaya w. s. r to polycystic ovarian syndrome p. 127
Kamini Balasaheb Bhingardive, Dattatray Durgadas Sarvade, Santoshkumar Bhatted
DOI:10.4103/ayu.AYU_192_16  
Background: Due to sedentary lifestyle and stress, the incidence of metabolic disorders are increasing day by day. Among these polycystic ovarian syndrome (PCOS) is an intricate disorder affecting 4%–8% women in their reproductive age and related to ovarian dysfunction characterized by obesity, oligomenorrhea, anovulation and hyperandrogenism. In modern system of medicine, the available allopathic regimen has its own limitations, so it is need of time to find a safe and effective alternative therapy for such type of condition. The most common symptom in 85%–90% of PCOS patients is oligomenorrhea which can be correlated to Artava Kshaya (loss of menstrual fluid) in Ayurveda. Hence, in the present clinical study, Vamana Karma (therapeutic vomiting) with Ikshwaaku seed formulation followed by Shatapushpadi Ghanavati was planned. Aims: To evaluate the efficacy of Vamana Karma (therapeutic vomiting) followed by Shatapushpadi Ghanavati in the management of Aartava Kshaya (loss of menstrual fluid) w. s. r to PCOS. Materials and Methods: A total of 15 patients of PCOS were clinically diagnosed and treated by Vamana Karma (therapeutic vomiting) procedure with Ikshwaaku seed formulation. After completion of Vamana Karma (therapeutic vomiting) and Samsarjana Krama, (post therapy dietary regimen for revival) Shatapushpadi Ghanavati 2 Vati (each 500 mg) twice in a day with lukewarm water was given for 45 days. After completion of 2-month trial, assessment of therapy was estimated by subjective and objective parameters. Results: Statistically extremely significant (P < 0.0001) results were found in menstrual irregularities, obesity, and body mass index. The significant result in reduction of nondominant follicles (P = 0.01 and 0.03 for right and left ovary, respectively), lowering the fasting blood sugar level (P = 0.02) and hirsutism (P = 0.03) was found. Conclusion: Vamana Karma (therapeutic vomiting) followed by Shatapushpadi Ghanavati is very effective in the management of obese PCOS patients and increasing chances of conception.
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Clinical efficacy of Baladi Manduram in the management of Amlapitta p. 133
Hanumanthu Kishore Kumar, CH Sridurga, Dabbu Bhaskar Rao
DOI:10.4103/ayu.AYU_201_17  
Background: Amlapitta is a commonly encountered disease of Annavaha Srotasa (gastrointestinal system) described in various classical Ayurvedic texts. The cardinal features of Amlapitta are Avipaka (indigestion), Hritkantha Daha (heart and throat burn) and Tikta-Amlodgara (sour and bitter belching). This disease can be correlated with gastroesophageal reflux disease based on the clinical features. Baladi Manduram is one of the unique formulations mentioned in Rasa Kamadhenu indicated for the management of Amlapitta. Aims: This study is aimed to evaluate the efficacy of Baladi Manduram in the management of Amlapitta. Materials and Methods: A non-randomized, single-armed, open-labeled clinical trial was conducted in thirty patients having classical symptoms of Amlapitta, administered with 500 mg of Baladi Manduram twice a day after meals for 30 days. The assessment was done based on subjective parameters, i.e., Amlodgara (sour belching), Daha (heart burn), Gaurava (heaviness), Utklesha (nausea), Avipaka (indigestion) and Kshudha Alpata (loss of appetite). The results were statistically analyzed using the paired t-test. Results: Statistically highly significant relief (P < 0.001) was noted in Amlodgara, Hritkantha Daha, Utklesha and Agnimandya and statistically highly significant relief (P < 0.01) was seen in Gaurava and Avipaka. Conclusion: Baladi Manduram can be considered as an effective formulation in the management of Amlapitta.
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CASE REPORTS Top

Management of internal bleeding piles by ligation and plication followed by Matra Basti - A case report p. 139
Narendra Singh Shekhawat, Meenakshi Singh, Rajesh Gupta, Om Prakash Dave
DOI:10.4103/ayu.AYU_147_17  
Arsha (hemorrhoids) is engorgement of the hemorrhoidal venous plexus, characterized by bleeding per rectum, constipation, pain in ano, prolapse and discharge per anum. It is a primary disease, with impaired digestion as the underlying pathogenesis. It is manifested due to improper diet, prolonged standing and faulty habits of defecation causing derangement of Tridosha, mainly Vata Dosha. Vitiated Dosha localizes in Houstan's Valve, rectal arteries, fascia and vitiates Skin, muscles, adipose tissue and blood due to Annavaha Srotodushti (vitiation of gastrointestinal tract). A 45-year-old male patient came to the OPD of Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University hospital, Jodhpur, Rajasthan, with complaints of prolapsing pile mass during defecation, pain per anum with erosion and bleeding per anum while passing stool. On proctoscopy, pile masses were seen at 11 and 3 O'clock positions and few erosions were seen near the 3 O'clock pile mass. The case was diagnosed as “Raktarsha”- later stage of 2nd degree internal hemorrhoids at 11 and 3 O'clock positions, deeply situated, projecting one and caused by Pitta and Rakta Dosha; with bleeding tendency. Ligation of pile mass by surgical linen barbour thread number 20 on 11 O'clock positions and plication by absorbable chromic catgut on 3 O'clock positions of internal hemorrhoid were done under local anesthesia followed by Matra Basti (therapeutic oil enema) with Jatyadi oil. The pile mass and per rectal bleeding resolved in 10 days and the patient got relief from all the symptoms within 4 weeks. No complications were reported after the procedure. The patient was followed up regularly from the registered date onward till 3 months and proctoscopic examination did not revealed any evidence of recurrence of the hemorrhoids.
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A single-case study of management of Jalodara (ascites) p. 144
Shital Gopalbhai Bhagiya, Ram B Shukla, Nayan P Joshi, Anup B Thakar
DOI:10.4103/ayu.AYU_176_17  
Most common manifestation of liver dysfunction is ascites and most common cause of ascites is liver disease. Ascites is the accumulation of fluid in the peritoneum. Inspite of advanced medical facilities, still, there is no sure treatment which cures a patient of ascites totally. The modern treatments only provide provisional relief with time dependent recurrence but, the fluid gets collected in the abdominal cavity repeatedly. In such case, Ayurvedic treatment gives relief without any side effect, in such cases and can be correlated with Jalodara (ascites) which mentioned in Ayurveda medical science. Diet restriction, medicinal treatment and surgical procedure are mentioned in Samhita. Diet restriction is an important feature of the management of this condition. A 46-year-old female came to outpatient department with anorexia, abdominal distension, vomiting after meal, respiratory distress etc. She was given Nitya Virechana (daily therapeutic purgation) with Abhayadi Modaka, cow's urine, Sharapunkha Swarasa, Punarnava Kwatha, etc. and restricted diet plan for 3 months. After 3 months, a significant improvement was noted in all the symptoms of the patient. Hb% was also increased from 7.5% to 11.2% and erythrocyte sedimentation rate and serum creatinine were decreased from 35 mm/h to 10 mm/h and 1.2 mg/dl to 0.9 mg/dl respectively. Ultrasonographic findings also showed improvement in comparison with previous report. Hence, it was concluded that Ayurvedic management gives relief in ascites.
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Management of premature contractions with Shatavaryadi Ksheerapaka Basti - A case report p. 148
MS Anu, Suprabha Kunjibettu, S Archana, Laxmipriya Dei
DOI:10.4103/ayu.AYU_200_17  
Premature contraction of the uterus is the very first sign of premature labour, which is followed by progressive changes in cervix such as effacement and dilatation. Four or more uterine contractions with or without pain per hour is a major biophysical predictor of preterm labour. According to the WHO statistics, every year, an estimated 15 million babies are born preterm and this number is rising. Although tocolytic agents are used to suppress premature contractions and prevent preterm labour, it is not proven to be efficacious in preventing preterm birth or reducing neonatal mortality or morbidity. As per Ayurveda, Akala Prasava (preterm labour) results due to the malfunctioning of Apana Vata (a type of Vata Dosha which is responsible for the excretory action). Basti (medicated enema therapy) is considered the best for managing the deranged Apana Vata. Basti is also indicated in Garbhini Paricharya (routine antenatal care) after completion of seven months of pregnancy. In this present case study, Shatavaryadi Ksheerapaka Basti (medicated enema prepared along with milk) was administered in a 28 year old second gravida patient of 33 weeks gestation with premature contractions, wherein isoxsuprine hydrochloride proved to be ineffective. Per-rectal Basti with 450 ml Shatavaryadi Ksheerapaka administered for 2 consecutive days was found to be effective in preventing the uterine contractions and further advancement to preterm labour. The drugs in Shatavaryadi Ksheerapaka Basti possess antioxytocic and vasodilating properties which may effectively curtailed the progress of premature contractions.
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PHARMACOGNOSTICAL STUDY Top

Detailed cyto-anatomy and cytometry of Cassia mimosoides L. leaf - An unexplored plant p. 153
Gautam Fichadiya, CR Harisha
DOI:10.4103/ayu.AYU_188_17  
Background: Cassia mimosoides L. is one of the nonclassical folklore plants of Gujarat, known as Aval ni jaat. Root and leaves of this plant are used in diarrhea, wound healing and mouth ulcers by tribal people. Aims and Objectives: Review revealed that the leaf part of this plant are unexplored from the pharmacognostical aspects. Hence, the present study focuses on the pharmacognostical study of leaf along with its powder. Materials and Methods: Collection, macroscopy and microscopy have been carried out as per standard protocol. Observation and Results: The leaves are alternate, compound with opposite glabrous leaflets. T. S. of rachis consists of epidermis, pericycle and vascular bundle. T. S. of dorsiventral leaflet shows epidermis and vascular region with 1/5 palisade ratio. Leaf powder is dark green in color. Palisade parenchyma cells, rhomboidal crystals and unicellular warty trichomes are present in the powder of leaf. Discussion: Yellow pentamerous flowers and paracytic stomata are key characteristics of genus Cassia. The value of stomatal index always remains constant even in different environmental conditions which play a very significant role in the identification of plant. Conclusion: Microscopy of leaf and its powder of Cassia mimosoides can be helpful in identifying the plant in powder form and the values can be helpful in further standardization.
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PHARMACEUTICAL STUDY Top

Analytical profile of Kukkutanda Tvak Bhasma (incinerated hen egg shells) prepared by two different methods p. 158
Thakur Rakesh Singh, Krishna M Fanasiya, Prashant Bedarkar, BJ Patgiri, PK Prajapati
DOI:10.4103/ayu.AYU_209_17  
Background: Kukkutanda Tvak Bhasma (KTB) (incinerated hen egg shells) is one of the important calcium-rich medicines used to treat leukorrhea, urinary tract infections, etc. Ancient scholars suggested that KTB prepared with processed Hingula (cinnabar) is more potent than Bhasma prepared without Hingula. Hence, in the present study, an attempt has been made to prepare incinerated hen egg shells using two different methods with and without cinnabar and their analytical profiles have been developed. Aims and Objectives: To develop analytical profile of KTB prepared by two different methods. Materials and Methods: Two samples of KTB were prepared. Sample KTB-A was prepared by Kumari Swarasa (juice of Aloe vera Tourn. Linn.) and sample KTB-B was prepared in the presence of Hingula as a medium for Marana using electric muffle furnace. The final product of both the samples of Bhasma were analyzed by organoleptic characteristics, physicochemical parameters and advanced sophisticated instrumental technologies such as particle size detection, inductively coupled plasma-atomic emission spectroscopy, Fourier transfer infrared spectroscopy, X-ray diffraction (XRD) and scanning electron microscopy. Observations and Results: 22.75% and 41.16% of Calcium was detected in samples KTB-A and KTB-B, respectively. 0.29% and 0.15% of magnesium was found in samples KTB-A and KTB-B respectively. Both the samples of Bhasma were found to contain calcium hydroxide Ca(OH)2. Conclusions: Minimum four Puta (incineration cycles) with average 800°C temperature is required to prepare KTB through electric muffle furnace using Kumari Swarasa and processed Hingula as a medium. An average particle size was found as 9.35 μm and 9.97 μm in samples KTB-A and KTB-B, respectively. XRD study reveals that raw Kukkutanda Tvak is CaCO3 (calcite) and CaCO3 (calcium carbonate) whereas both the Bhasma contain CaH2O2 (portlandite syn) and Ca(OH)2.
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PHARMACOLOGICAL STUDIES Top

Comparative evaluation of antidiabetic potential of partially purified bioactive fractions from four medicinal plants in alloxan-induced diabetic rats p. 165
Twinkle S Bansode, BK Salalkar, Pandurang Dighe, Sunil Nirmal, Santosh Dighe
DOI:10.4103/ayu.AYU_18_17  
Background: Syzygium cumini, Terminalia chebula, Trigonella foenum graecum and Salvadora persica are medicinally important plants well known for their pharmacological activities. Aim: The aim of this study is to compare the antidiabetic potential of partially purified bioactive fractions isolated from four targeted medicinal plants in diabetic rats. Methods: Alloxan was administered (125 mg/kg, IP) in albino Wistar rats to produce diabetes. The partially purified bioactive fractions, namely S. cumini tannin fraction (ScTF), T. foenum graecum (Fenugreek) saponin fraction (FgSF), T. chebula flavonoid fraction (TcFF) and S. persica flavonoid fraction (SpFF), were administered to diabetic rats with the dose of 100 mg/kg, per oral (PO) and the effect of the fractions on body weight, liver glycogen and serum glucose were studied up to 15 days. Results: The results have indicated that diabetic rats treated with fractions showed a statistically significant (P < 0.05) decrease in serum glucose and increase in body weight and liver glycogen. Among ScTF, FgSF, TcFF and SpFF possesse better hypoglycemic activity in all models. Conclusion: The present investigation reveals that flavonoid isolated from S. persica is useful in the management of diabetes mellitus because of ability to regulate glucose level and reduce related complications.
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Ninety days repeated dose oral toxicity study of Makaradhwaja in Wistar rats p. 171
Shrirang Jamadagni, Pallavi Shrirang Jamadagni, Rajendra Kumar Singh, Sachchidanand Upadhyay, Sudesh N Gaidhani, Jayram Hazra
DOI:10.4103/ayu.AYU_33_17  
Context: Makaradhwaja is a Kupipakwa Rasayana. Since it contains two heavy metals, namely mercury and gold, it is essential to evaluate its safety. Hence, the present study was undertaken with an objective to evaluate toxicity and target organ of toxicity of Makaradhwaja if so. Aims: The objective was to evaluate toxicological profile, the target organ of toxicity and to find no observed effect level (NOEL) or no observed adverse effect level (NOAEL) in rats after oral administration for ninety consecutive days. Materials and Methods: Makaradhawaja preparation was administered to male and female Wistar rats for ninety consecutive days at 2.7, 13.5, and 27 mg/kg body weight. All relevant biochemical and hematological changes were observed. At termination, all the rats were sacrificed and necropsy was performed. Histopathological evaluation was also performed. Statistical Analysis Used: Dunnett's test followed by analysis of variance. Results: There was a significant increase in high-dose group kidney weight of both sexes which could not be correlated with histopathology findings and serum biochemistry. Therefore, the change was not considered as an adverse effect. Conclusions: The dose level 27 mg/kg of Makaradhwaja was found as NOAEL and dose level 13.5 mg/kg of Makaradhwaja was found as NOEL.
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