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| CLINICAL RESEARCH |
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| Year : 2011 | Volume
: 32
| Issue : 2 | Page : 241-249 |
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A clinical study on the role of Agnimanthadi compound in the management of Sthaulya (obesity)
Ravikant Goyal1, Mandip Kaur2, HM Chandola3
1 Reader, Department of Panchakarma, SDM College of Ayurveda, Hassan, India
2 Assistant Professor, Department of Kayachikitsa, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India
3 Professor and Head, Department of Kayachikitsa, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India
| Date of Web Publication | 2-Feb-2012 |
Correspondence Address:
Mandip Kaur
Assistant Professor, Department of Kayachikitsa, Institute for Post Graduate Teaching and Research in Ayurveda, Jamnagar, Gujarat
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/0974-8520.92553
 Abstract | | |
Sthaulya (obesity) has become so common in the World's population that it is beginning to replace undernutrition and infectious diseases as the most significant contributor to ill health. It exacerbates a large number of health-related problems, both independently and in association with other diseases. Therefore, this study was carried out at PG Hospital, IPGT and RA, Jamnagar to evaluate effect of Agnimanthadi compound in the patients of Sthaulya. For this purpose 83 patients of Sthaulya were selected out of which 15 patients were dropped out. Remaining 68 patients were treated in two groups. Among these, 38 patients of Sthaulya were treated with Agnimanthadi compound administered orally in the dose of four capsules of 500 mg three times a day with lukewarm water before meal. Remaining 30 patients of Sthaulya were kept as placebo control and were administered orally two placebo capsules of 500 mg filled with starch, three times a day with lukewarm water before meal. The duration of the treatment in both the groups was 7 weeks with follow-up for 2 months. Analysis of overall effects of both the groups showed that Agnimanthadi compound provided markedly better reduction in weight, BMI and other signs and symptoms in the patients of obesity in comparison to the control group. Keywords: Agnimanthadi compound, obesity, sthaulya
How to cite this article:
Goyal R, Kaur M, Chandola H M. A clinical study on the role of Agnimanthadi compound in the management of Sthaulya (obesity). AYU 2011;32:241-9 |
| Introduction | |  |
Sthaulya is included under eight undesirable conditions (Ashtau Nindita),[1] Shleshma Nanatmaja,[2] Samtarpana Nimittaja,[3] Atinindita,[4] Ati Brihmana Nimittaja[5] and Bahu Dosha Janita[6] Vikara. Moreover Sushruta has emphasized on metabolic disturbances (Dhatvaagnimandya) in the etiopathogenesis of Sthaulya.[7] The patient of Sthaulya exhibits very strange phenomenon. Their appetite is excessive [8] and whatever they eat is quickly digested, which indicates hyperfunctioning of the Jatharaagni. Besides this, the patient suffers from laziness, may be due to under supply of energy, which may be due to hypofunctioning of Bhutaagni. Further Dhatvaagni also seems to be disturbed, as in Sthaulya patient mainly Medo-Dhatu is formed and there is deficiency of other Dhatu.[9] Hence, it can be inferred that in Sthaulya, Jatharaagni is Tikshna, Bhutaagni is Manda and Dhatvaagni is disturbed in their respective functions. On the basis of the above-mentioned facts of pathogenesis of Sthaulya, it can be said that the drug, which decreases Jatharaagni particularly Abhyavaharana Shakti, increases Bhutaagni and corrects the functions of Dhatvaagni and at the same time have Medo-hara, Kapha-hara and Vatahara actions, may be suitable for its management.
Taking all the above mentioned facts in consideration, Agnimanthadi compound comprising of Agnimantha, Mustaka, Gomutra and Eranda Patra Kshara was formulated for the present study. Most of these drugs are indicated in the treatment of Sthaulya in Ayurvedic classics. [10]
Agnimantha (Clerodendrum phlomidis (Burm.f.) Kuntze) is Dipana, Pachana, Kaphaghna, Shothahara and is having Vata-Kapha Hara properties.[11] Its antidiabetic action [12] is also reported which may be due to its action at the level of Bhutaagni and Dhatvaagni. Mustaka (Cyperus rotundus Linn) has Dipana, Pachana, Lekhana, Mutrala and Pitta Shamaka actions. [13] To make both drugs more Tikshna, seven Bhavana of Gomutra were given. Gomutra is Tikshna, Ushna and Agni-Dipaka in action [14] and has Kapha Vata Nashaka properties. It is also indicated in the treatment of Sthaulya by Sushruta.[7]
In clinical practice it is observed that Agnimantha produces burning sensation. Hence, Eranda (Ricinus communis Linn) Patra Kshara was added in the compound, which is reported to have Kapha Nashaka, Medohara, Dipana and Pachana actions. [15]
Objective
- To evaluate the efficacy of Agnimanthadi compound in the management of Sthaulya (obesity)
| Materials and Methods | | |
The 83 patients of Sthaulya (obesity) attending the OPD and IPD of PG Hospital, IPGT and RA, Gujarat Ayurveda University, Jamnagar were registered for this study. Out of these, 15 patients were dropped out and 68 patients completed the prescribed course of the treatment.
Criteria of diagnosis
The diagnosis was mainly based on the clinical presentation as mentioned in the Ayurveda texts as well as Allopathic texts along with body mass index (BMI). A detailed proforma incorporating all the clinical aspects mentioned for Sthaulya/obesity was prepared accordingly, detailed clinical history was taken and physical examination was done.
Criteria for selection of patients
Patients in the age group of 16-65 years were selected for the present study. Other criteria for inclusion was as follow:
Subjective criteria
- Patients having clinical presentation of Sthaulaya (obesity) as mentioned in the Ayurveda texts as well as allopathic texts.
Objective criteria
- For the present study BMI more than 30 was taken for considering the patients as obese and the patients having BMI 30-45 were included for the present study.
BMI calculated on the basis of height and weight of each patient, Standard range of normal body weight in relation to height mentioned by Life Insurance Corporation of India was adopted. An international criterion for BMI was used to calculate the BMI by the following formula:
BMI = weight (in kg)/Height (in meter).
Exclusion criteria
- Patients in the age group of less than 16 years and more than 65 years were not included for the present study.
- Obese patients suffering from hypothyroidism, obesity due to hormonal imbalance, cardiovascular diseases, hemiplegia, associated with severe hypertension and from other such diseases in which the patient cannot do his routine physical activities were excluded.
- Very obese patients having BMI more than 45 were excluded from the present study.
Investigations
- Lipid profile was carried out approximately in all the patients before and after the study and fasting blood sugar was carried out in suspected cases only.
Other examination and tests
- Weight was recorded before starting the treatment and later on every week of the study. Weight was also recorded of all the patients who have come for the follow-up study.
- Circumferences of fatty parts were recorded before and thereafter every week, till the completion of the course of treatment, to assess the effect of therapy.
- The effectiveness of therapy on body fat was assessed by measuring the skin fold thickness by vernier calipers before and after the treatment in particular areas of middle portions of the biceps and triceps muscles, middle portion of the suprailiac region and the anterior surface of mid-thigh region and of abdominal muscle at umbilicus.
- Walking time: The time taken to climb fixed number of stairs in seconds was taken as walking time.
Groups division and treatment
Eighty-three patients of Sthaulya were registered for this study and were divided into two groups' viz. Placebo control group and Agnimanthadi group. Out of which 15 patients were dropped out and 68 patients of Sthaulya completed the full-course of the treatment and their details were as follow:
Out of 68 patients of Sthaulya who completed the full-course of the treatment 30 patients were treated in the placebo control group and 38 patients were treated in Agnimanthadi group. This difference in number of patients in both the groups was due to more dropouts in the control group.
- Control (C) Group: The patients of this group were given two placebo capsules three times a day with lukewarm water before meal for seven weeks. Each capsule was filled with 500 mg of starch.
- Agnimanthadi (A) Group: Patients of this group were administered Agnimanthadi compound in the dose of 2 g (four capsules of 500 mg) three times a day with lukewarm water before meal for a period of 7 weeks.
Method of preparation of drug
Agnimanthadi compound comprises of four drugs namely Agnimantha, Mustaka, Eranda Patra Kshara and Gomutra. First of all, fine powders of Agnimantha and Mustaka were taken in equal quantity. The mixture of these two powders was given seven Bhavanas of Gomutra and at the end Eranda Patra Kshara was added to it. Sixteen parts of Gomutra Bhavita Agnimantha and Mustaka was added to the one part of Eranda Patra Kshara. This compound was filled in the capsules.
Duration of treatment
Duration of treatment for both the groups was 7 weeks.
Criteria of assessment
The effect of therapy was assessed on the basis of the following subjective as well as objective criteria.
Subjective criteria
A multidimensional scoring pattern was adopted for the sign and symptoms of Sthaulya mentioned in Ayurvedic texts. The score of symptom was assessed before and after the treatment and statistical analysis was undertaken. Apart from cardinal sign and symptom other signs and symptoms were also assessed. This assessment was done before starting the treatment and thereafter every week till completion of seven week course of therapy. The paired 't' test was applied for the statistical analysis of the results. Moreover assessment of Dosha, Dushya, Srotasa based on their dominant symptoms was also carried out.
Objective criteria
For objective criteria above mentioned parameters mentioned under the heading of investigations and examination and tests were taken into consideration.
Assessment of overall effect of the therapy
For the overall assessment of the therapy following eight categories were taken into consideration:
- Complete remission: 100% relief in the signs and symptoms, along with reduction in body weight up to normal range, for that particular height in comparison of age, was considered as complete remission.
- Marked improvement: More than 75% improvement noted in signs and symptoms, along with more than 75% weight reduction, was considered as markedly improved.
- Moderate improvement: Fifty to 75% improvement was noted in the sign and symptoms along with more then 50% weight reduction was considered as moderate improvement.
- Improvement: If 25-50% improvement was noted in the sign and symptoms along with more then 25% weight reduction, then it was considered as improvement.
- Slight improvement: Less than 25% relief in sign and symptoms along with less than 25% weight reduction was considered as slight improvement.
- Unchanged: No effect in sign and symptoms along with no change in weight was considered as unchanged.
- Deterioration: Increase in signs and symptoms or appearance of new symptoms or increase in weight was considered as deterioration.
- Change of score: If improvement was noted in sign and symptoms, but no improvement or mild increase of weight was recorded, then one step down improvement was assigned. Same was followed vice-versa.
Follow-up study
After completion of due course of treatment, all the patients were asked to report for follow-up study for the period of 2 months. In follow-up study statistical changes in body weight, chest circumference, hip circumference, abdomen circumference, abdomen skin fold measurement (SFM) and hip SFM were observed.
Observations
In the present series of 83 patients of Sthaulya (obesity), maximum number of patients were in the age group of 21-50 years (74.69%), female (80.72%), Hindu by religion (65.1%), married (84.34%), belonging to lower middle socioeconomic class (51.81%) and were from urban habitat (98.8%).
In this series maximum number of patients were of Kapha-Vata Prakriti (50.60%) followed by Kapha-Pitta Prakriti (49.39%).
The 50.60% patients of this series were vegetarian, 69.88% were having habit of Adhyashana, 92.77% patients were doing sedentary work, 98.79% were not doing exercise at all, 84.34% patients were having sound sleep and 69.88% were jolly in nature.
Majority of the patients in this series i.e., 93.97% each were taking Guru Guna and Shleshma Guna dominant diet, 83.13% patients were satisfied only after ingestion of 50% more than their routine diet requirement and 43.37% of the patients were taking food 3-4 times in a day.
In this series all the patients were having the symptoms of Sphika Chalatva (100%), Anga Gaurava (100%), Anga Shaithilya (100%) and Ati Kshudha (100%). Other signs and symptoms observed were Atipipasa (93.97%), Daurbalya (92.77%), Ayasena Shvasa (91.6%), Utsahahani (92.77%), Svedabadha (87.95%), Nidraadhikya (84.34%), Gatra Sada (98.8) and Udara Chalatva (84.33%).
Main Srotodushti observed in patients of this series were Medovaha (100%), Rasavaha (98.79%), Udakavaha (97.59%), Maajjavaha (84.34%), Pranavaha (90.36%), Svedavaha (87.95%), Annavaha (78.31%), Mutravaha (62.65%) and Purishvaha (60.24%).
Maximum numbers of the patients were having Body weight in the range of 71-90 kg (60.24%) and BMI between 31 and 36 (50.60%). Maximum number of the patients i.e., 43.37% had 11-20 kg more weight than ideal body weight followed by 30.12% patients having 21-30 kg more weight than ideal body weight and 48.19% patients were suffering from Sthaulya from 5.1 to 10 years.
In this series maximum number of patients were having cholesterol in the range of 151-200 mgm/100 ml (54.2%), serum triglyceride in the range of 101-150 (30.12%), HDL in the range of 41-50 (37.25), LDL more than 150 (77.1%) and VLDL in the range of 21-30 (38.55%).
Effects of Agnimanthadi compound
Agnimahthadi compound provided statistically highly significant reduction of 2.14% in the body weight and 1.86% in BMI [Table 1]. As shown in [Table 2] and [Figure 1], it provided statistically highly significant relief in Utsaha Hani (30.58%), Daurbalyata (28.41%), Anga Gaurava (25.67%), Nindradhikya (23.88%), Gatra Sada (22.05%) and Aayasena Shvasa (19.4%). | Table 1: Comparison of the effects of therapies on body weight and BMI of 68 patients of Sthaulya
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 | Table 2: Effect of Agnimanthadi compound on the sign and symptoms of 38 patients of Sthaulya
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It provided statistically highly significantly reduction of 2.43% in increased pulse rate [Table 3], 4.71% in diastolic blood pressure [Table 4], 9.56% in serum cholesterol [Table 5], 4.98% in walking time [Table 6] and of 0.77% in total SFM [Table 7]. | Table 3: Comparison of the effects of therapies on pulse rate of 68 patients of Sthaulya
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 | Table 4: Comparison of the effects of therapies on diastolic blood pressure of 68 patients of Sthaulya
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 | Table 5: Comparison of the effects of therapies on lipid profile of 68 patients of Sthaulya
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 | lTable 6: Comparison of the effects of therapies on walking time of 68 patients of Sthaulya
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 | Table 7: Comparison of the effects of therapies on various SFM of 68 patients of Sthaulya
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It significantly reduced the systolic blood pressure by 1.68% [Table 8], the circumferences of Mid-arm by 2.70%, forearm by 2.70%, mid thigh by 1.91%, chest by 1.11%, abdomen by 1% and hip by 1% [Table 9] and [Figure 2]. | Table 8: Comparison of the effects of therapies on systolic blood pressure of 68 patients of Sthaulya
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 | Table 9: Comparison of the effects of therapies on various of 68 patients of Sthaulya
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It provided statistically highly significant relief of 53.61% in Sroto Dushti symptoms of Annavaha and of 33.80% in Rasavaha Srotasa [Table 10]. It also significantly increased the symptom of Ati Mutratata by 25.39% [Table 2] which showed its diuretic effect. | Table 10: Comparison of the effects of therapies on Sroto Dushti of 68 patients of Sthaulya
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The overall effect showed that Agnimanthadi compound provided moderate relief in 5.26%, Improvement in 13.16 and, slight improvement in 63.16% patients. In this group 5.26% patients remained Unchanged and 5.26% patients were further deteriorated [Table 11]. | Table 11: Overall effect of Agnimanthadi compound group on38 patients of Sthaulya
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In follow-up study [Table 12], highly significant reduction (P < 00.001) in body weight was observed in one month follow-up [Table 13]. But, this significant reduction was not sustained in the second month of follow-up study [Table 13]. | Table 13: Follow-up study of the patients of Sthaulya in Agnimanthadi compound group
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Effect of control group
Placebo in control group provided slight reduction in body weight and BMI but both the findings were not statistically significant [Table 1]. It provided significant relief in the symptoms of Daurbalyata (31.50%), Utsaha Hani (28.57%), Aayasena Shvasa (23.1%), Anga Gaurava (19.11%) and Nidradhikya (11.96%) as shown in [Table 14]. It significantly reduced diastolic blood pressure by 2.26% [Table 4] and ratio of Serum LDLC/HDLC by 16.55% and Serum TC/HDLC Ratio by 15.06% [Table 5]. It also provided significant relief in Rasavaha Sroto Dushti by 23.7% [Table 10]. | Table 14: Effect of control (placebo) on the sign and symptoms of 30 patients of Sthaulya
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Considering the overall effect showed that treatment with placebo provided improvement to 33.33% patients and slight improvement to 40%. In this group 6.67%. patients remained unchanged and 20% patients were further deteriorated [Table 15].
| Discussion | | |
In the present series, 83 patients fulfilling the criteria for the diagnosis of Sthaulya were selected. Out of which 15 patients had left the treatment at different stages. The remaining 68 patients completed full course of treatment for the period of 7 weeks, out of which 30 patients were in placebo control group and 38 patients were in Agnimanthadi compound group.
Comparison of the results of both the groups showed that Agnimanthadi compound provided better relief to the patients of Sthaulya than control group in the symptoms of Utsaha Hani, Anga Gaurava, Nindradhikya, Gatra Sada, Snigdha Angata and Sveda Abadha; and Dushti Lakshana of Annavaha Srotasa and Rasavaha Srotasa.
Agnimanthadi compound also imparted comparatively better and significant reduction [Table 1] in the body weight and BMI in comparison to the control group. It also showed comparatively better reduction on all circumferences of fatty parts of the body [Table 9] viz. biceps SFM, triceps SFM, suprailiac SFM and total SFM [Table 7], walking time [Table 6], pulse rate [Table 3] and diastolic blood pressure [Table 4].
It also provided comparatively better relief in serum cholesterol, serum LDL and serum LDLC/HDLC Ratio [Table 5].
On the other hand control group provided better relief in comparison to Agnimanthadi compound only in the two symptoms [Table 14] viz. Daurbalayta and Ayasena Shvasa. It also provided better effect on serum LDLC/HDLC ratio and serum TC/HDLC ratio [Table 15].
Comparison of the overall effects of the therapies
Agnimanthadi compound provided better improvement in overall signs and symptoms and laboratory findings related to Sthaulya in comparison to the Control group [Table 11] and [Table 15] [Figure 3]. | Figure 3: Overall effect of the therapies on the 68 patients of Sthaulya
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The results of the follow-up study showed, highly significant reduction (P < 0.001) in body weight in one month follow-up [Table 13]. But, this significant reduction was not sustained in the second month of follow-up study [Table 13]. On the other hand no such effect was noticed in Placebo group at the follow-up study [Table 16].
Agnimanthadi compound comprises of Agnimantha, Mustaka. Eranda Patra Kshara and Gomutra, which are have Dipana, Pachana, Medohara and Kaphahara actions. Due to these properties of the drugs, Agnimanthadi Compound may have acted on hypo function of Bhutagni which was noticed by its significant effect on Annavaha Srotaso Dushti and on Utsah Hani and Daurbalyata which indicates it has effect at the level of Bhutagni. Medohara action of these drugs has provided significant effect on all the sign and symptoms of Sthaulya.
| Conclusion | | |
The present placebo controlled clinical study was carried out on the patients of Sthaulya to evaluate the effects of Agnimanthadi compound administered orally in the dose of 2 g three times a day for 7 weeks. On the basis of the results of this study following conclusions may be drawn:
- Agnimanthadi compound provided significant relief in the symptoms of Ayasena Shvasa, Utsaha Hani, Daurbalyata, Nidra Adhikya, Sveda Abadha, Snigdha Angata, Angagaurava, Atipipasa and Ati-Kshudha.
- Agnimanthadi compound significantly reduced the body weight and BMI of the patients of Sthaulya.
- Agnimanthadi compound provided significant relief in the Dushti Lakshana of Annavaha Srotasa and Rasavaha Srotasa.
- Agnimanthadi compound significantly reduced all the circumferences of fatty parts of the body viz. biceps SFM, triceps SFM, suprailiac SFM and total SFM.
- Agnimanthadi compound also significantly improved the walking time and reduced the increased pulse rate and diastolic blood pressure.
- Agnimanthadi compound also provided comparatively better relief in serum cholesterol, serum LDL, serum LDLC/HDLC ratio [Table 5].
- Agnimanthadi compound provided moderate relief in 5.26%, improvement in 13.16 and and slight improvement in 63.16% patients. In this group 5.26% patients remained unchanged and 5.26% patients were further deteriorated.
- In most of the cases the beneficial effects of Agnimanthadi compound were better in comparison to the placebo control group.
[16]
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[Figure 1], [Figure 2], [Figure 3]
[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], [Table 15], [Table 16]
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