Ayurvedic management of Sthaulya with Triphaladighanavati and Vaman and Virechan Panchakarma.
- Conditions
- Obesity, unspecified,
- Registration Number
- CTRI/2019/06/019883
- Lead Sponsor
- Self Dr Sagar Gopal
- Brief Summary
**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 *Ayurved*ic 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 *Samsarjankrama***2ndAssesment** 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 *Ayurved*ic 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 70
-
- Patients having clinical features of Sthaulya with respect to Ayurveda classics.
- 2)Patients of Sthaulya having BMI more than 25Kg/m2and less than 35Kg/m2.
- (Obese-1 & Obese- 2).
- 3)Patients of either sex aged between 18- 70 years irrespective of caste, religion, socio economic & educational status.
- 4)Those patients of Sthaulya who are willing to participate in trial and ready to give written consent will be included.
- 1)Patients of obesity due to hypothyroidism, Cushing’s syndrome and obesity with any other systemic disorders like Ischemic heart disease will be excluded.
- 2)Patients of Sthaulya with hypertension and diabetes mellitus will be excluded.
- 3)Patients of drug induced obesity for example Hormonal replacement therapy, consumption of anabolic steroids etc.
- will be excluded.
- 4)Pregnant females & lactating mothers will not be considered.
- 5)Patients who are currently participating in other clinical trials (since last six months) will be excluded.
- 6)Those patients who are contra indicated for Vamana and Virechana.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Triphaladighanavati after Vamana have equal effect as that of Triphaladighanavati after Virechana in Sthaulya in reducing weight and Body Mass Index. 52 Days
- Secondary Outcome Measures
Name Time Method 1)To evaluate the effect of Vamana followed by Triphaladighanavati on insulin resistance (HOMA-IR) [16] and to compare its result with that of Virechana followed by Triphaladighanavati. 52 Days
Trial Locations
- Locations (1)
Government Ayurved Hospital Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
Government Ayurved Hospital Nagpur🇮🇳Nagpur, MAHARASHTRA, IndiaDr Sagar Anil GopalPrincipal investigator8888980476sagargopal007@gmail.com