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Introduction

Ayurveda as a holistic science recommends various regimens which help human being to achieve healthy living, while modern scientific medicine concentrates to a large extent on curative aspect of the disease. Medoroga or sthaulya is a major lifestyle disorder whose prevalence has increased drastically over a past few decades. According to Acharya Charaka Sthaulya has been classified under "Ashta Nindit Purusha" (eight despicable personalities).[1] Acharya Sushruta has narrated the aetiopathogenesis of Sthaulya Roga because of an endogenous entity being caused due to "Dhatvagni Mandya".[2]

Sthaulya (obesity) is a non-communicable disease, which provides the platform for so many hazards like Hypertension, Cardiovascular disease, diabetes and Osteoarthritis, infertility, Impotency as well as psychological disorders like stress, anxiety, depression. A person having pendulous appearance of sphika, udara and stana due to excess deposition of meda along with mansa dhatu and having unequal an abnormal distribution of Meda with reduced zeal towards life is called “Atisthula”.[3] Sthaulya is the disease of Medodhatvagni Vikriti. If Agni will be good and potent, through passing from the level of Rasagni, Raktagni and Mamsagni the Medodhatuvriddhi will occur and if Agni will be poor, it will create Dhatvagnimandya. So, Rasagata, Raktagata, Mamsagata and Medogata Snehamsa will be increased due to their own Dhatvagnimandya respectively. [4] In Sthaulya, completed nourishment of only Meda dhatu cause malnourishment of all other dhatus including Asthi Dhatu.[5] Medodushti Symptoms like Atinidra, Angagaurava, Alasya,, Tandra, Vistrashariragandha, Shaithilya are found as Purvarupa of Medoroga. [6] The cardinal or Pratyatma Lakshana of Sthaulya have been described by Acharya Charaka as Chala Sphika, Chala Udara, Chala Stana, Ayatha Upachaya, Anutsaha etc.[7] In this study total 60 patients of Sthoulya taken for the study. Experimental group treated with Guduchyadi Yoga 3 gm thrice a day along with koshna jala and Control group treated with Triphala churna along with Koshna jala.

Objectives:

1. To study the effect of Guduchyadi Yoga in Sthaulya w.s.r. Obesity.

2. To study the effect of Triphala churna in Sthaulya w.s.r. Obesity.

3. To compare the effectiveness of Guduchyadi Yoga and Triphala churna.

Material and methods:

Study  design: Randomized Clinical Trial.

Selection of patient: OPD and IPD of Kayachikitsa, M.S.Ayurveda College and Hospital,Gondia.

Inclusion criteria: Patients fulfilling diagnostic criteria and signs and symptoms of Sthaulya between 20 to 60 years age. Patient who was ready to participate and give consent.

 Exclusion criteria: Patients having BMI less than 25 kg/m2 and having complications such as diabetes, cardiovascular disease, other systemic complications like malignancies or having hepato/renal problems. Patients having poorly controlled blood pressure >160/100 mm of Hg. Patients on prolonged medication (>6weeks) with corticosteroids.

Withdrawal criteria: If patients  develop any adverse effect and not responding to treatment.

Sample size: Total 60 patients were recruited and allotted equally 30  in each group.

Subjective parameters:

A) Karya –anutsaha (Lack of enthusiasm)-

1. Presence of enthusiasm.                 0
2. Does routine work without enthusiasm.1
3. Can do routine work only when forced to do so.2
4. Cannot do routine work despite of force or pressure.3

B) Daurbalya (Weakness)

1. Absent        0
2. Performing own work (like defecation& bath) but feeling of weakness to perform other work.1
3. Performing routine work with a slight feeling of weakness.       2
4. Only sitting at a place or inability to even stand without support.3

C) Swedadhikya (Excessive sweating):-

1. Normal Sweda                       0
2. Sweating up to garments especially at axillary & groin region.1
3. Excessive sweating at axilla, groin & sweating at all over body.2
4. Sweating &wetting of clothes, wetting & oozing of garments.3

D) Kshudrashvasa (Tachypnoea):-

1. Normal respiratory rate 12-16 per minutes-0
2. Increased R.R on one hour of continuous routine physical work            1
3. Increased R.R on more than one and half hour of sedentary work. 2
4. Increased R.R on very less physical work or sedentary work.3

E) Daurgandhya (Body odour)  

1. No body odor (Absent)                      0
2. Mildoffensive, self-attainable body odour.1
3. Moderate offensive & attainable by near person.2
4. Severe offensive & attainable by distance. 3

F) Kshudhadhikya (Excessive appetite)

1. Norma appetite.  0
2. Hunger after timely meal.1
3. Hunger after timely meal, followed by restlessness,weakness & irritability if desire not fulfilled.2
4. Continuous hunger without satisfaction irrespective of meal. 3

G) Nidradhikya (Excessive Sleep) –

1. Normal sleep (7-8 hours per day)               0
2. Normal sleep without cheerfulness in senses.    1
3. Increased duration of sleep with lack of energy. 2
4. Desire to sleep continuously with lack of energy. 3

Objective parameters:

1.    Height(cm)

2.    Weight (in kg).

3.    Body mass index (BMI)

4.    Waist circumference (cms)

5.    Abdomen Circumference

6.    Hip circumference(cms)

7.      Waist: HIP Ratio (WHR)

Treatment details: Table no. 1

Observations & results:

In this study, totally 28 [46.7%] patients were male & 32[53.3%] were female while more female was recruited in experimental group it may be due random selection of patients. Age: As per inclusion criteria of patients were selected having age between 20 years to 60 yrs. And distributed it in four-sub age groups. Out of 60 patients’ number of patients found in age group 20-30 were 11 [18.3%], in 31 to 40 yrs. were 06 [10%], in 41 to 50 yrs. age group 21[35%], and in age group 51-60 yrs. Were 22 [36.7%], in numbers and percentage respectively.

Subjective criteria of Sthaulya in Experimental and Control Group

Effect of Intervention seen on every follow up i.e. Day 30, 60 and 90 days for the symptoms Karya-Anutsah, Daurbalya, Swedadhikya, Kshudrashwas, Daurgandhya, Kshudhadhikya and Nidradhikya in both group , it was observed that there highly significant difference observed on each follow p.. Comparison done within each follow up by Dunn’s multiple comparisons test. In all these symptoms intervention was seen highly significant on Day 90 follow ups compare to Day 30 and day 60. The effect was seen significantly in symptoms like Karya-Anutsah not different as compare to Day 0 and Day 30 as p value obtained was >0.05. There was no significant difference found at Day 0 and Day 60 also. However, p value obtained was <0.001 which is considerably highly significant on Day 0 and Day 90. So, it can be concluded that there was significant difference in symptom Karya-Anutsah on day 90 as compare to day 0.

Table No. 2 Gender Wise Distribution of Patient of Sthaulya

Table No.3 Comparison for Subjective Criteria between the groups by Mann-Whitney ‘U’ Test

Table No.4 Showing Effect of Therapy on subjective parameters of 30 Patients of Sthaulya of Experimental Group (Test Applied was Repeated measure ANOVA)

Table 5. Effect of Intervention seen for Weight on every follow up i.e. Day 30,60 and 90 days. Multiple comparisons test Tukey Kramer done further in Experimental Group.

Table No.6 Showing Effect of Therapy on subjective parameters of 30 Patients of Sthaulya of Control Group (Test Applied was Repeated measure ANOVA)

Table no. 7 Effect of Intervention seen for Weight on every follow up i.e. Day 30,60 and 90 days. Multiple comparisons test Tukey Kramer done further in control group.

Table No. 8 Showing Effect of Comparison Between Group w.r.t Objective parameters of 60 Patients of Sthaulya (Test Applied was Unpaired T –Test)

in Experimental Group. In parameter Weight, the effect of intervention was seen significantly different as compare to Day 0 and Day 30 as p value obtained was <0.05. There was highly significant difference found at Day 0 and Day 60, and Day 0 and Day 90 as p value obtained was <0.001. So, it can be concluded that there was significant difference in parameter Weight on Day 30,60 and 90 as compare to day 0.

In control group, Effect of Intervention seen for Weight on every follow up i.e.Day 30,60 and 90 days. In parameter Weight, the effect of intervention was seen found not significantly different as compare to Day 0 and Day 30, Day 60 and Day 90 as p value obtained was >0.05. There was no significant difference found at Day 0 and Day 30, and Day 0 and Day,60 and Day 90 as p value obtained was >0.05. So, it can be concluded that there was no significant difference in parameter Weight on Day 30,60 and 90 as compare to Day 0.

For comparison of Objective parameters of 60 Patients of Sthaulya ‘Unpaired test’ was applied for both experimental and Control group. Regarding the Weight the Mean ± SD of Exp. Group was 2.50±1.50 and in Control Group, it was 1.79±1.36 where reduction of weight is more in experimental group than in Control group and t value obtained is 1.92 with 58 degree of freedom p value obtained is 0.06 which is not significant statistically. So it can be concluded that there is no difference in both group statistically. Experimental group intervention is equally effective to the Control group intervention.

Like in BMI (Body Mass Index) the p value obtained is <0.04 which can be considered as significant statistically. So, it can be concluded that there is difference in both group statistically and Experimental group intervention is better than Control group intervention. In Abdomen circumference the p value obtained is <0.01 which can be considered as significant statistically. So, it can be concluded that there is difference in both groups statistically and Experimental group intervention is better than Control group intervention. However, in Waist circumference, Hip and Waist Hip Ratio the value obtained is >0.05 which is not significant statistically. So, it can be concluded that there is no difference in both the group statistically. Experimental group intervention is equally effective to the Control group intervention.

Discussion

In the disease Sthaulya, Tikshnagni is occurs. Here, Jatharagni is found in excessive condition whereas Medodhatvagni is found in Manda condition. It is due to Avarana of Vayu in Kostha. So, person indulges more food, which produce excessive Meda and vitiated cycle go on. This cycle is broken (Samprapti Vighatana) by Katu-Rasa & Ushna-Virya Pradhana drugs – Triphala and Guduchyadi Yoga which decreases Meda by its Lekhana, Shoshana and Kaphanashaka properties, Kaphanashaka properties due to Agni and Vayu Mahabhuta dominance in them (Su.Su15). Triphala also having Medakaphahar properties alongwith it enhances agni and ultimately it helps in increasing lekhan and dhatwagni so the samprapti is broken for further meda preparation.

 The Difference between before intervention and after intervention score of both groups compared by ‘Mann-Whitney U Test’. It was found that the sum of rank for the symptom Karya anutsaha Mann Whitney U’ statistics was 475, Test statistic (U) was 425, where the test statistic U was not between Population Mean ±1.96 SD which was consider as not significant at 5% level of significance. (P>0.05) Therefore the difference between Symptom Score of Karya anutsaha of Experimental and Control group is not statistically significant, so therefore we can conclude that in the symptom Karya anutsaha both interventions are equally effective statistically.

                However, in the symptoms Daurbalya, Swedadhikya, Kshudrashvasa, Daurgandhya, Kshudhadhikya, Nidradhikya which was not significant at 5% level of significance as the p value > 0.05 hence in these symptoms experimental group and Control group intervention is equally effective statistically. For comparison of Objective parameters of 60 Patients of Sthaulya ‘Unpaired test’ was applied for both experimental and Control group. Regarding the Weight the Mean ? SD of Exp. Group was 2.50±1.50 and inControl Group, it was 1.79±1.36 where reduction of weight is more in experimental group than in Control group and t value obtained is 1.92 with 58 degree of freedom p value obtained is 0.06 which is not significant statistically. So it can be concluded that there is no difference in both group statistically. Experimental group intervention is equally to the Control group intervention. Like in BMI (Body Mass Index) the p value obtained is <0.04 which can be considered as significant statistically. So it can be concluded that there is difference in both group statistically and Experimental group intervention is better than Control group intervention. In Abdomen the p value obtained is <0.01 which can be considered as significant statistically. So, it can be concluded that there is difference in both groups statistically and Experimental group intervention is better than Control group intervention. However, in Waist, Hip and Waist Hip Ratio the value obtained is >0.05 which is not significant statistically. So, it can be concluded that there is no difference in both the group statistically. Experimental group intervention is equally to the Control group intervention. Overall it was observed that Percentage of Relief in Each Patient of 60 Patients of Sthaulya in experimental group was 55.79 while 49.60 % in Control group. On an average in both group 52.70 % relief got in each patient of Sthaulya.

Mode of action:

Guduchyadi Yoga

Guduchyadi Yoga contains Guduchi, Musta encounters Vata & Kapha Dosha by virtue of its Katu,Kashay-Rasa dominance & Ushna-Virya.  Meda & Kleda are the chief culprits in Sthaulya. Katu-Rasa performs Medo-Kledopa-Shoshana action.  Sthairya Guna of Madhura Rasa combats Sharira Shaithilya. Ushna-Virya also helps in Kleda and Meda Vilayana action. Katu-Rasa, Ushna-Virya encounters Dhatwagnimandya & potentiates the weakened Dhatwagni and help in Amapachana thereby alleviates Aparipakwa and Ama dhatu.Ultimatellit act as medohar and breaks the Samprapti of Sthaulya.

Triphala Churna:

It contains Amalaki, Haritaki and Bhibitak. Haritaki is lagu,Rukhsa and Ushna veerya due to which it act as Vatahar , it also help in Deepana karma and amapachak. Due to Katu-Rasa, Amalaki & Bhibhitak Haritaki hhg katu rasa,kaghu, ruksha all the involved channels are dilated i.e. “Srotansi Vivrunoti” action. Katu-Rasa and Ushna-Virya check over Medovaha and Mamsavaha Srotodushti, it helps in medohar action. In nut cell in Triphala Churna all ingredient have Katu Ras & Laghu, Ruksha and Ushna Virya, Katu Vipak, Vata-Kaphashamak, Karshana, Lekhaniya, Medorogahara, Amapachana, Dhatu shoshana properties, which normalize the state of Agni. Thus, regulated Jatharagni, checked the excessive growth and accumulation of Medodhatu and thereby causing Lakshana Upshamana of disease Sthaulya.

Limitation & Scope of study:

Study duration could be longer for better results. Along with medicine patients of obesity can also be iced for exercise and Pathyapathya. Drug can be given in Vati or tablet form. Patient counselling need to be done for diet and exercise management.

Conclusion

Guduchyadi Yoga and Triphala churna are found both equally effective in subjective parameters like Karya –anutsaha Daurbalya, Swedadhikya, Kshudrashvasa, Daurgandhya, Kshudhadhikya, Nidradhikya of Obesity. Mean reduction of weight in experimental group was 2.50 kg and in Control group in control group it was 1.79 kg however it is not significant statistically.

Overall it was observed that Percentage of Relief in Each Patient of 60 Patients of Sthaulya in experimental group was 55.79 while 49.60 % in Control group. On an average in both group 52.70 % relief got in each patient of Sthaulya.