“Randomised Controlled Trial on Principles of Management of Sthaulya by Triphaladighanavati after Vamana Specifically on Body Mass Indexâ€

Introduction

Obesity is a major lifestyle disorders, it is a disease which grows rapidly ranking one of the most common chronic metabolic disorder.

Obesity in Ayurveda described under the heading of Sthaulya. Charak has described Sthaulya as a disease of accumulation of excessive Meda and Mamsa Dhatu, which result into pendulous appearance of buttocks, belly and breast. Atisthula has been classified under Ashta Ninditiya Purush. Sushruta opined that some of Upadrava of Sthaulya are Prameh Pidaka, Jwar, Bhagandar, Vidradhi and Vatvikara. Charak described eight Dosha of Sthaulya like Javoparodha, Daurbalya, Daurgandhya etc. Charak also explain the Samprapti of Sthaulya.

Vagbhat advocated Shodhana Chikitsa in Sthaulya. There is involvement of dominant Kapha Dosha and Meda Dhatu so it is thought in mind to evaluate the effect of Vamana followed by Shamana and to compare its results with that of Virechana followed by Shamana in the management of Sthaulya with special reference to Obesity. Effect of Virechana followed by Triphaladighanavati was evaluated by Gaonkar A. (2018) submitted to M.U.H.S. Nashik. She was of the opinion that Virechana followed by Triphaladighanavati significantly reduced weight and total cholesterol. She further added that even administration of Snehapana also reduced weight significantly. Therefore, it was thought in mind that to compare the result of Vamana followed by Triphaladighanavati with that of Virechana

Materials and Methods:

1)     Medium of Dissertation: Language will be in English and Sanskrit words will be used wherever necessary.

2)     Study Type: Randomised Controlled Trial.

3)     Study Centre: OPD and IPD of Kayachikitsa Department of the Institute.

4)     Duration of Study: 18 months.

5)     Duration of Treatment: Trial Group-20 Days Vamana+30Days [Shamana].

Control Group -22 Days for Virechana+30 days [Shamana].

6)     Ethical Clearance: From ethics committee of the Institute.

7)     Medium of Dissertation: Language will be in English and Sanskrit words will be used wherever necessary.

8)     Study Type: Randomised Controlled Trial.

9)     Study Centre: OPD and IPD of Kayachikitsa Department of the Institute.

10)  Duration of Study: 18 months.

11)  Duration of Treatment: Trial Group-20 Days Vamana+30Days [Shamana].

Control Group -22 Days for Virechana+30 days [Shamana].

12)  Ethical Clearance: From ethics committee of the Institute.

Criteria of Diagnosis:

1.     Clinical examination of all patients will be carried out as mentioned in Classics [7] along with investigations which ever necessary for diagnosis.

2.     Sign and symptoms of obesity will also be considered.

The BMI must be in range of more than 25kg/m2 and less than 35kg/m2(obese-1 and obese-2

Trial Group

Rukshana Pachan Kvath 20 ml BD will be given to the Sthaulya patients for 5 Days then Snehapana by Triphaladi Tailpana as 30ml, 45ml, 60ml, 75 ml, 90ml etc till Samyaka-Sneha. After that local application of Sneha and Sveda for one day then Vamana by Madanphala Pippali Yastimadhu Phanta and Samsarjanakrama according to Shuddhi. after Samsarjanakrama Triphaladighanavati 500mg 2 BD with Ushnodak at Apanakala will be given for 30 days

Control Group

Rukshana Pachan Kvath 20ml BD will be given to the Sthaulya patients for 5 Days then Snehapana by Triphaladi Tailpana as 30ml, 45ml, 60ml, 75ml, 90ml etc till Samyaka-Sneha. After that local application of Sneha and Sveda for three days then Virechana by Ichhabhedi Rasa 250 mg 1 stat early morning with cold water and Samsarjanakrama according to Shuddhi. after Samsarjanakrama Triphaladighanavati 500mg 2BD will be given for 30 days.

Assessment of patients and Differentiation:

Vamana Group:

Assessment of patients will be done on the basis of clinical feature as per Ayurvedic text, body mass index, waist hip ratio, lipid profile, Serum Insulin (fasting), before starting treatment that is on zero days.  These criteria will be assessed, which will be termed as Before Treatment (B.T. Score).  After Vamana treatment, that means on next day after completion of Samsarjankrama2ndAssesment will be done i.e. Before Shamana assessment will be taken, then follow-up will be taken after one-month course of Triphaladighanavati and this will be termed as After Treatment score (A.T. score).

The patient will be examined every day during Snehapana and Vamana. After completion of treatment the efficacy treatment will be assessed by following subjective as well as objective criteria.

Virechana Group:

Assessment of patients will be done on the basis of clinical feature as per Ayurvedic text, body mass index, waist hip ratio, lipid profile, Serum Insulin (fasting). Before starting treatment that is on zero day these criteria will be assessed, which will be termed Before Treatment (B.T. Score), after Virechana treatment that means on next day after Samsarjan Krama 2ndAssesment will be done. It will be Before Shamana assessment. Then follow-up will be taken after one-month course of Triphaladighanavati and this will be termed as After Treatment score (A.T. score).

Discussion and conclusion:All the Data will be recorded on C.R.F. These will be classified and will be tabulated in the form of Master Chart. All these will be summarized and analyzed. The matter of Data will be decided and they will be tested by statistical test. That test may be either paired t test or Wilcoxon Signed Rank Test. Further comparison between two groups will be done with the help of either unpaired t test or Man Whitney test. Overall effect of therapy between the two groups will be compared by Chi Square test. Results obtained in two groups will be discussed with the therapeutics. The cause will be described that why such results are obtained with the reasoning where ever possible. Conclusion will be drawn with the help of results of this study.