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ORIGINAL ARTICLE
Year : 2018  |  Volume : 39  |  Issue : 2  |  Page : 65-71  

A clinical evaluation of Kanchanara Guggulu and Bala Taila Matra Basti in the management of Mutraghata with special reference to benign prostatic hyperplasia


1 Department of Shalya Tantra, IPGT and RA, Gujarat Ayurved University, Jamnagar, Gujarat, India
2 Department of Shalya Tantra, AIIA, New Delhi, India

Date of Web Publication24-Jan-2019

Correspondence Address:
Dr. Gajiram Dharamdas Banothe
Department of Shalya Tantra, IPGT and RA, Gujarat Ayurved University, Jamnagar - 361 008, Gujarat, India
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ayu.AYU_117_15

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   Abstract 


Background: Mutraghata a disease of Mutravaha Srotasa (urinary system) described in Ayurveda, closely resembles with benign prostatic hyperplasia (BPH) of the modern medicine. It affects man above the age of 40 years. Conservative management with hormonal therapy, open prostatectomy and TURP are the options available in modern medicine. In Ayurveda, the drugs having Vata Kapha pacifying action, Shothahara (anti-inflammatory) and Mutrala (diuretic) are recommended for its management. Aim: The aim of this study was to evaluate the clinical efficacy of Kanchanara Guggulu orally and Bala Taila Matra Basti in the management of Mutraghata (BPH). Materials and Methods: A total of 32 selected patients were divided into two groups. In group A, Bala Taila 60 ml, Matra Basti, once a day, was administered just before breakfast for 21 days. In group B, Bala Taila (60 ml), Matra Basti, once a day, was administered just before breakfast for 21 days and Kanchanara Guggulu Vati 1g (2 tab, 500mg each) three times a day, orally with lukewarm water was administered for 21 days. Findings were recorded in research proforma at weekly interval and patients were followed up till 1 month. Results: In group A, the maximum improvement was seen in 3 patients (25.00%), moderate improvement was seen in 8 patients (66.67%) and mild improvement was observed in 1 patient (8.34%). Similarly, in group B, the maximum improvement was found in 10 patients (55.56%), moderate improvement in 7 patients (38.89%) and mild improvement in 1 patient (5.56%) only. None of the patients got complete remission or remained unchanged in either of the groups. Significant reduction was observed in postvoidal residual urine volume and the size of the prostate in both the groups. Conclusion: It was concluded that Matra Basti along with Kanchanara Guggulu orally showed Mutraghata comparatively better symptomatic relief as compared to Matra Basti alone in cases of Mutraghata (BPH).

Keywords: Ayurveda, Mutravaha Srotasa, Prostate, TURP


How to cite this article:
Banothe GD, Mahanta V, Gupta SK, Dudhamal TS. A clinical evaluation of Kanchanara Guggulu and Bala Taila Matra Basti in the management of Mutraghata with special reference to benign prostatic hyperplasia. AYU 2018;39:65-71

How to cite this URL:
Banothe GD, Mahanta V, Gupta SK, Dudhamal TS. A clinical evaluation of Kanchanara Guggulu and Bala Taila Matra Basti in the management of Mutraghata with special reference to benign prostatic hyperplasia. AYU [serial online] 2018 [cited 2019 Mar 22];39:65-71. Available from: http://www.ayujournal.org/text.asp?2018/39/2/65/250771




   Introduction Top


In Ayurveda, Mutraghata has been defined as a syndrome of obstructive urinary pathology due to deranged function of Vata Dosha, particularly Apana Vata (a type of Vata responsible for excretory function). Twelve types of Mutraghata[1] are mentioned in Sushruta Samhita Uttaratantra. The symptoms such as retention of urine, incomplete voiding, dribbling, hesitancy and incontinence of urine are found in Mutraghata; these features probably reflect lower urinary tract symptoms. Based on these features, Mutraghata bears a close resemblance with benign prostatic hyperplasia (BPH). BPH is a nonmalignant enlargement of the prostate gland caused by excessive growth of the prostatic tissue and is the most common benign neoplasm of aging men mainly above 40 years.[2] The overall incidence rate of BPH is 15/1000 men/year. The prevalence of histologically diagnosed prostatic hyperplasia increases from 8% in men aged 31–40 years, to 40–50% in men aged 51–60 years and to >80% in men elder than 80 years.[3] The management of BPH is either through a surgical approach (e.g. open prostatectomy, transurethral resection of the prostate, cryotherapy etc.) or by conservative treatment using drugs (e.g. hormonal therapy) in the modern medicine. In case of hormonal therapy, though there are some advantages, the complications such as loss of libido, impotence and gynecomastia are unwanted effects encountered in clinical practice. In a surgical procedure, prostatectomy is choice, but it also has many complications like postoperative morbidity, impotence, retrograde ejaculation etc. The other procedure is Transurethral Resection of the Prostate (TURP), which is also not free from complications and recurrence rate is around 15% in 5–8 years after TURP.[4] In Ayurveda, Sushruta has given regimen consisting of Kashaya (decoction), Kalka (paste), Ghrita (medicated ghee), Kshara (alkalizers), etc. to combat this condition.[5] The formulations having property of pacification of Vata, Vatanulomana, anti-inflammatory, scraping and diuretic effect and therapeutic procedures such as Matra Basti and Uttara Basti are recommended to normalize the function of urinary system by reducing the size of the prostate, clearing the bladder outlet obstruction and to enhance the tone of urinary bladder. Matra Basti is treatment for vitiated Vata where no strict restrictions are required. Hence, this research work was planned to assess the efficacy of Kanchanara Guggulu, which has Vata-Kapha pacifying, anti-inflammatory, cyst dissolving properties and Bala Taila Matra Basti in the management of Mutraghata (BPH).

Aims and objectives

The aim of this study was to evaluate the clinical efficacy of Kanchanara Guggulu (KG) orally and Bala Taila Matra Basti in the management of Mutraghata with special reference to BPH.


   Materials and Methods Top


The patients having signs and symptoms of Mutraghata (BPH) were selected from the outpatient department and inpatient department of Shalya Tantra. The trial formulations Bala Taila and Kanchanara Guggulu (KG) were prepared and supplied by Pharmacy, Gujarat Ayurved University, Jamnagar. Before registering the patients in clinical trial, clearance from the Institutional Ethics Committee was obtained, vide letter no. PGT/7-A/Ethics/2013-14/1767 Dated 10/09/2013. The trial has been registered in CTRI with registration No. CTRI/2015/07/006010, date of first enrolment was February 19, 2014 and date of completion of the trial was January 20, 2015.

Inclusion criteria

  • Age between 40 and 70 years
  • Patients having classical signs and symptoms of Mutraghata (BPH).


Exclusion criteria

  • Age below 40 years and above 70 years
  • Patients of malignancy, congenital deformities of the urogenital tract or any abdomino-pelvic pathology other than BPH
  • Systemic diseases such as uncontrolled systemic arterial hypertension and diabetes mellitus, tuberculosis, paralysis and  Parkinsonism More Details known cases of heart disease were excluded from the study


Diagnostic criteria

  • Patients having signs as enlarged prostate size and decreased urinary flow rate and symptoms like retention, incomplete voiding, dribbling, hesitancy and incontinence of urine were diagnosed as a case of Mutraghata (BPH)
  • International Prostate Symptom Score (IPSS) (based on the guidelines of American Urological Association) was used to evaluate subjective complaints of patients before and after the administration of the therapy, average urine flow rate (AUFR) measurement (manually), ultrasonography (USG) findings of the prostate gland and post voidal residual urine (PVRU) volume and per rectal digital examination for the prostate was also done.


Investigations

  • In all patients, the following laboratory and radiological investigations were carried out before and after treatment
  • Routine hematological examination: Hb%, complete blood count, erythrocyte sedimentation rate
  • Biochemical examination of fasting blood sugar, postprandial blood sugar, serum creatinine, serum alkaline phosphatase and blood urea
  • Routine and microscopic examination of urine and stool
  • USG abdomen and prostate
  • X-ray kidney, ureter, and bladder.


Trial drugs

  1. Bala Taila (BT): The contents of Bala Taila are Atibala (Abutilon indicum (L.) Sweet)[6] and Tila Taila (Sesamum indicum L.)[7] which were prepared as per the Snehapaka Kalpana (clssical procedure to prepare medicated oil) and procured from Pharmacy Gujarat Ayurved University, Jamnagar
  2. Kanchanara Guggulu (KG): It was prepared as per the reference given in Sharangdhara Samhita.[8]


Clinical study design

Registered patients by coin-toss method were divided into two groups, group A (Bala Taila Matra Basti) and group B (Bala Taila Matra Basti and Kanchanara Guggulu). All the patients were followed up till 1 month.

  • Group A: Bala Taila Matra Basti 60 ml once a day, administered to selected 12 patients before breakfast for 21 days
  • Group B: Bala Taila Matra Basti 60 ml was given once a day, administered to selected 18 patients, before breakfast for 21 days along with Kanchanara Guggulu orally 1g (2 tab., 500mg each) three times a day after food with lukewarm water for 21 days.


Assessment criteria

Subjective criteria

  1. Improvement in the symptoms as per the IPSS.[9]


Objective criteria

  1. Changes in residual urine volume. [Table 1]
  2. Changes in urine flow rate. [Table 2]
  3. Changes in prostatic size as assessed by per rectal digital examination and USG study. [Table 3]
Table 1: Gradation of residual urine volume

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Table 2: Gradation of urine flow rate

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Table 3: Gradation of prostate size (volume)

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Overall assessment criteria

  • Complete remission: 100% relief in subjective, objective findings and IPSS parameters
  • Maximum improvement: 76%–99% relief in subjective, objective findings and IPSS parameters
  • Moderate improvement: 51%–75% relief in subjective, objective findings and IPSS parameters
  • Mild improvement: 26%–50% relief in subjective, objective findings and IPSS parameters
  • Unchanged: Up to 25% relief in subjective, objective findings and IPSS parameter.


General observations

  • All patients were vegetarian and consuming Madhura Rasa (sweet taste) and Snigdha Guna (oily) food articles, 46.87% of patients were having irregular bowel habit and 37.5% patients had habit of passing hard stool. Maximum 59.37% patients had chronicity of disease up to 1 year [Table 4].
  • In the present study, nocturia and increased frequency of micturition was found in 87.50% patients. Similarly, other symptoms such as weak stream, dribbling, incomplete voiding, burning micturition and urgency was observed in 81.25%, 75%, 68.75%, 65.63% and 62.50% of the patients respectively. None of the patients suffered from hematuria or dysuria [Table 5].
  • As per per-rectal examination, maximum patients (53.13%) were noted having prostate enlargement of both lobes, oval shaped (84.37%) with smooth surface (100%). The upper border of the prostate was not approachable in 53.13% patients, median groove of the prostate was palpable in 87.50% and free rectal mucosa and firm consistency of prostate were noted in 100% cases. The size of the prostate gland was mildly enlarged in 59.37% of patients [Table 6].
Table 4: General observations (n = 32)

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Table 5: Symptoms wise distribution as per IPSS

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Table 6: Per rectal digital examination findings (n = 32)

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   Results Top


Laboratory investigations

In both of the groups in significant changes ere found in most of haematological and biochemical parameters.[10][Table 7]
Table 7: Effect of therapy on investigations in Group B: (n = 18)

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Result on International Prostate Symptom Score

Statistically highly significant relief (P < 0.001) was recorded in chief complaints like nocturia, increased frequency of micturition, incomplete voiding, dribbling and weak stream, while significant relief (P < 0.01) was noted in burning micturition and urgency in group A [Table 8]. Statistically highly significant (P < 0.001) result was noted on almost all symptoms in patients of group B [Table 9].
Table 8: Effect of therapy on IPSS in Group-A (n = 12)

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Table 9: Effect of therapy on IPSS in Group-B (n = 18)

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Result on objective parameters

Statistically highly significant (P < 0.001) increase was noted in AUFR and significant (P < 0.01) reduction was recorded in prostate size as well as PVRU in group A [Table 10]. Statistically highly significant (P < 0.001) effect in reducing PVRU and increasing AUFR and significant (P < 0.05) decrease in the size of enlarged prostate gland was noted in patients of group B [Table 11].
Table 10: Effect of therapy on objective parameters in Group-A: (n = 12)

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Table 11: Effect of therapy on objective parameters in Group-B (n = 18)

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Overall result of therapy (group wise)

In group A, maximum improvement was seen in 3 patients (25.00%), moderate improvement was seen in 8 patients (66.67%), and mild improvement was observed in 1 patient (8.34%) [Table 12]. Similarly, in group B, maximum improvement was found in 10 patients (55.56%), moderate improvement in 7 patients (38.89%) and mild improvement in 1 patient (5.56%) only. None of the patients had complete remission or remained unchanged in either of the groups [Table 13].
Table 12: Overall Effect of therapy in Group A: (n = 12)

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Table 13: Overall effect of therapy in Group B (n = 18)

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Overall effect of therapy

Maximum improvement i.e. 76.67 % was found in the symptoms like retention of urine, incomplete voiding, dribbling, hesitancy and incontinence of urine. While mild improvement (40.00%) was observed in average urine flow rate (AUFR), post voidal residual urine (PVRU) volume and size of the prostate. [Table 14]
Table 14: Overall effect of therapy on different parameters (n = 30)

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   Discussion Top


In Ayurveda, Mutraghata is a broad term as it covers most of the pathological entities of the urinary system. Total, 12 types of Mutraghata are mentioned by Acharya Sushruta[11] and 13 types by Acharya Charaka. Mutraghata comprises of two different words, that is, “Mutra” means urine and “Aghata” means obstructive pathology. The features of Mutraghata such as retention of urine (Mutrasanga) and pain in suprapubic region are observed due to obstructive pathology and can be correlated with BPH on the basis of its symptoms and signs. In old age, there is deranged function of Vata Dosha, particularly Apana Vata which is the prime causative factor and it also disturbs with Kapha Dosha. Consequently, vitiated Vata and Kapha Dosha affect to Mutravaha Srotasa and derangments occurs in Basti (urinary system) and results in Mutraghata. Hence, the drugs having Vata-Kapha pacifying property, Srotoshodhana (cleaning the channels), Lekhana (scraping), Shophahara (anti-inflammatory), Mutrala (diuretic) and along with digestive properties are helpful to break the Samprapti of Mutraghata ( BPH).

Kanchanara Guggulu is an Ayurvedic formulation having properties of Vata-Kapha Dosha pacification, Lekhana and Shothahara (anti-inflammatory).[12] Because of these properties, Kanchanara Guggulu may check the changes of prostatic tissues and regulates the urinary function.[13] Matra Basti is the procedure to control Vata Dosha, especially Apana Vata.[14] All Acharya have recommended Matra Basti as a line of management of Mutraghata to improve urinary function and to remove the obstruction.

Most of the patients in this study (50%) were from the age group of 61–70 years. This age group favors the vitiation of Vata Dosha and might be a cause for the development of Mutraghata, especially hyperplasia of the prostate gland. Modern science has also reported that benign changes in the prostate gland are more prevalent in sixth and seventh decades of life. Most of the patients had chronicity up to 1 year. In the initial stage, the symptoms of BPH are not severe; hence, the patients ignore the complaints till the condition becomes chronic. Samashana (mixing of wholesome food with unwholesome food) was found in the majority of the patients. Ama (undigested food) is the causative factor for the manifestation of Mutraghata as described by Charaka and more formation of Ama is seen in the person habitual of Samashana. Disturbed sleep was found in maximum number of patients, which might be due to increased frequency of micturition at night. Constipation was found in 37.5% of the patients, which might be due to faulty dietary habits such as Samashana and deranged Apana Vayu.

In group A, Bala Taila Matra Basti provided 84.24% relief in incomplete voiding of urine, 77.42% relief in increased frequency, 77.78% relief in intermittency, 89.47% relief in urgency, 80% relief in weak stream, 84.62% in straining and 69.57% in nocturia. The quality of life was improved in 58.33% of patients. These results were highly significant (P < 0.001) in all of the above mentioned symptoms except intermittency, which was statistically significant (P < 0.01), whereas in objective findings, the size of the prostate was reduced up to 33.34%. Reduction of 88.89% was found in PVRU and AUFR was improved up to 75%. This encouraging result was found because Matra Basti has the potency to pacify vitiated Apana Vata, which is the prime factor for the manifestation of Mutraghata. The properties of Bala Taila such as muscle tone building, rejuvination and anti-inflammatory activities help to improve the function of the detrusor muscle. Atibala is an important ingredient of Bala Taila which contains saponin as a chemical component. It has diuretic and anti-inflammatory actions.[15] Hence, it is obvious that Bala Taila might have contributed in improvement of bladder function by increasing the bladder tone as well as reducing the size of the prostate. Ultimately the bladder outflow obstruction was improved and overall quality of life was improved with Matra Basti.

In group B, Kanchanara Guggulu and Bala Taila Matra Basti provided 71.74% rellief in incomplete voiding, 75% in increased frequency, 79.17% in intermittency, 80.65% in urgency, 82.86% in weak stream, 85.00% in straining and 79.63% in nocturia. The quality of life was improved up to 54.10%. These obtained results were statistically highly significant (P < 0.001), whereas in objective findings, the size of the prostate was reduced up to 16.67%, PVRU was improved up to 90.00% and 74.07% increase was observed in AUFR.

The drug Kanchanara Guggulu having the properties of Vata-Kapha Shamana, Pachana, Basti Shodhana and Mootrala etc., might have helped to enhance the function of the bladder. The drug Varuna (Crateva nurvala Buch.-Ham.) is one of the ingredients of this formulation containing Kampferol and quercetin flavonoids. These chemical constituents act as inhibitor of estrogenic receptor.[13] Hence, Kanchanara Guggulu was helpful in reducing the size of the prostate. Ingredients of Kanchanara Guggulu like, Triphala and Trikatu contains ascorbic acid which helps to relax the smooth muscle of the prostate and bladder neck to relieve pressure and improve urine flow rate.[16]

On comparison to the effect of therapy as per the IPSS pattern, group A has shown better result as compared to group B (79.15%). There was no statistically significant difference (P = 0.296) within two groups in the subjective parameters. It is suggested that changes that occurred with the treatment were not enough to exclude the possibility that the difference was due to chance. Hence, both groups had given parallel effect on symptoms/IPSS score of disease as per the statistical analysis.

According to all objective parameters such as prostate size, PVRU volume and average UFR, group A had shown better effect, that is, 65.74% relief as compared to group B (60.25%). But in both groups A- UFR was found increased statistically highly significant, whereas insignificant reduction (P > 0.05) were observed in prostate size and PVRU as per statistics.

Overall effect of therapy

During the entire period of therapy, there was no any untoward effect or adverse drug reaction observed in any of the patients of the group.


   Conclusion Top


This study concluded that 60 ml Bala Taila Matra Basti is effective and tolerable in the patients of Mutraghata (Benign Prostatic Hyperplasia). As the Benign Prostatic Hyperplasia is progressive degenerative disorder long term treatment may be needed to provide maximum relief in such patients.

Acknowledgment

The authors would like to thank Director, IPGT and RA, GAU, Jamnagar.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

1.
Ambikadutta SK, editor. Sushruta Samhita of Acharya Sushruta, Uttara Tantra. Ver 3-4. 17th ed., Ch. 58. Varanasi: Chaukhambha Sanskrita Sansthan; 2003. p. 539.  Back to cited text no. 1
    
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Walsh PC, Retik AB, Vaughan DE, Wein AJ, editors. Campbell's Urology. 7th ed. Tokyo: W.B. Soundess Company; 1992. p. 1036.  Back to cited text no. 2
    
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Guess HA, Arrighi HM, Metter EJ, Fozard JL. Cumulative prevalence of prostatism matches the autopsy prevalence of benign prostatic hyperplasia. Prostate 1990;17:241.  Back to cited text no. 3
    
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Norman SW, Christopher JK Bulstrode P. Ronan O'Connell, Bailey, Love: Short Practice of Surgery. 23rd ed. London and Oxford University, New York: Hodder Headline Group; 2000. p. 1247.  Back to cited text no. 4
    
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Ambikadutta SK, editor. Sushruta Samhita of Acharya Sushruta, Uttara Tantra. Ver. 27. 17th ed., Ch. 58. Varanasi: Chaukhambha Sanskrita Sansthan; 2003. p. 544.  Back to cited text no. 5
    
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Sharma PC, Yelne MB, Dennis TJ. Database in Medicinal Plants used in Ayurveda, New Delhi: CCRAS. Dept. of AYUSH. Vol. 4; 2002. p. 9.  Back to cited text no. 6
    
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Ambikadutta SK, editor. Sushruta Samhita of Acharya Sushruta, Uttara Tantra. Ver. 112. 17th ed., Ch. 45. Varanasi: Chaukhambha Sanskrita Sansthan; 2003. p. 230.  Back to cited text no. 7
    
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Vidhyasagar PS Pt., editor. Sharangadhara Samhita of Sharangadhara, Madyama Khanda. Ver. 82-83. 4th ed., Ch. 7. Varanasi: Chaukhamba Surbhaarati Prakashana; 2005. p. 205.  Back to cited text no. 8
    
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International Prostate Symptom Score (IPSS) at Urological Sciences Research Foundation. Available from: http://www.urospec.com/uro/Forms/ipss.pdf. [Last retrieved on November 2011]. [Last accessed on 2015 Feb 19].  Back to cited text no. 9
    
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Kamal Elden AM. Evaluation of acid and alkaline phosphate in benign prostatic hyperplasia and prostatic cancer patients. Tikrit Med J 2010;16:88.  Back to cited text no. 10
    
11.
Acharya YT, editor. Sushruta Samhita of Sushruta, Nibandha Sangraha, Uttara Tantra. Ver. 4. 9th ed., Ch. 58. Varanasi: Chaukhamba Surbharati Prakashana; 2009. p. 787.  Back to cited text no. 11
    
12.
Vidhyasagar Parshuram S Pt., editor. Sharangadhara Samhita of Sharangadhara, Madyama Khanda. Ver. 95. 4th ed., Ch. 7. Varanasi: Chaukhamba Surbhaarati Prakashana; 2006. p. 205.  Back to cited text no. 12
    
13.
Han HY, Shan S, Zhang X, Wang NL. Down-regulation of prostate specific antigen in LNCaP cells by flavonoids from the pollen of Brassica napus L., Phytomedicine 2007;14:338-43. Available from: http://www.sciencedirect.com. [Last accessed on 2015 February 19].  Back to cited text no. 13
    
14.
Acharya YT, editor. Charaka Siddhi Sthana. Ver. 64. 4th ed., Ch. 7. Varanasi: Chaukhamba Sanskrita Sansthana; 2002. p. 709.  Back to cited text no. 14
    
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Available from: http://www.stdpioneer.org/uti.html. [Last accessed on 2015 Mar 02].  Back to cited text no. 15
    
16.
Chaffay B. Effect of Ascorbic Acid and all Trans Retinoic acid on smooth muscle Cells Cultured on PCL Scaffolds. Electronic Thesis and Dissertation Repository; 2017. p. 4369. Available from: https://www.ir.lib.uwo.ca/etd/4369. [Last accessed on 2015 Mar 23].  Back to cited text no. 16
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10], [Table 11], [Table 12], [Table 13], [Table 14]



 

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