Randomized Clinical Comparative Study on the Effect of Virechana Followed with and without Dashanga Guggul in Sthaulya
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 3)To evaluate the effect of Snehpana followed by
Study Overview
Brief Summary
Obesity is a life style oriented disorder caused by excessive eating and lack of adequate exercise is discouraged by the society because of high incidence of Diabetes mellitus, hypertension, angina pectoris, and myocardial infarction etc.
In Ayurved it can be correlated with Sthaulya explained by different Acharya’s in their respective texts. Charaka included it in the eight varieties of impediments which is treated by Shodhana followed by Shamana.This is a project entitled “Open Randomized Study on Effect of Triphaladi Tailapana and Virechana Followed by Administrationof Dashanga Guggul in Sthaulyaâ€
All the parameters of assessment will be based on the signs and symptoms of Sthaulya mentioned in text.
Patients fulfilling the criteria will be selected and allocated in one group followed by a filling of consent form in language best understood by them. All the parameters will be assessed before and after treatment based on the specially prepared proforma. Appropriate test will be applied to the data outcome and discussion and conclusion will be made accordingly.
Study Design
- Study Type
- Interventional
- Allocation
- Random Number Table
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.patients of clinical features of Sthaulya.
- •2.body mass index from 25kg/m2 to 35kg/m
- •3.patients of Sthaulya with controled HTN and DM.
- •4.Patients with total cholesterol less than 300mg/dl.
Exclusion Criteria
- •1.Patients of obesity due to hypothyroidism Cushing’s syndrome, Steroid induced obesity or Obesity due to any other systemic disorders.
- •2.Drug induced obesity for example Hormonal replacement therapy, calcium channel blockers, consumption of anabolic steroids etc.
- •3.Pregnant females & lactating mothers.
- •4.Patients who are currently participating in other clinical trials (since last six months).
- •5.Obesity because of heredity will be excluded.
Outcomes
Primary Outcomes
3)To evaluate the effect of Snehpana followed by
Time Frame: 1)On zero day i.e. B.T.value | 2)Rukshana Pachana Kvath will be given for 5 | days. | 3)From 6th day Snehapana will be administered | for seven days and assessment will be done on | 13th day. | 4)Virechana will be given on 16 th day and | assessment will be done on 21 rst day. | 5) Final assessment will be done on 51 rst day | i.e. Dashanga Guggulu will be given for 30 days.
1)To evaluate the effect of Snehpana on body
Time Frame: 1)On zero day i.e. B.T.value | 2)Rukshana Pachana Kvath will be given for 5 | days. | 3)From 6th day Snehapana will be administered | for seven days and assessment will be done on | 13th day. | 4)Virechana will be given on 16 th day and | assessment will be done on 21 rst day. | 5) Final assessment will be done on 51 rst day | i.e. Dashanga Guggulu will be given for 30 days.
mass index, waist hip ratio and lipid profile.
Time Frame: 1)On zero day i.e. B.T.value | 2)Rukshana Pachana Kvath will be given for 5 | days. | 3)From 6th day Snehapana will be administered | for seven days and assessment will be done on | 13th day. | 4)Virechana will be given on 16 th day and | assessment will be done on 21 rst day. | 5) Final assessment will be done on 51 rst day | i.e. Dashanga Guggulu will be given for 30 days.
2)To evaluate the effect of Snehpana and
Time Frame: 1)On zero day i.e. B.T.value | 2)Rukshana Pachana Kvath will be given for 5 | days. | 3)From 6th day Snehapana will be administered | for seven days and assessment will be done on | 13th day. | 4)Virechana will be given on 16 th day and | assessment will be done on 21 rst day. | 5) Final assessment will be done on 51 rst day | i.e. Dashanga Guggulu will be given for 30 days.
hip ratio and lipid profile.
Time Frame: 1)On zero day i.e. B.T.value | 2)Rukshana Pachana Kvath will be given for 5 | days. | 3)From 6th day Snehapana will be administered | for seven days and assessment will be done on | 13th day. | 4)Virechana will be given on 16 th day and | assessment will be done on 21 rst day. | 5) Final assessment will be done on 51 rst day | i.e. Dashanga Guggulu will be given for 30 days.
Virechana separately on body mass index, waist
Time Frame: 1)On zero day i.e. B.T.value | 2)Rukshana Pachana Kvath will be given for 5 | days. | 3)From 6th day Snehapana will be administered | for seven days and assessment will be done on | 13th day. | 4)Virechana will be given on 16 th day and | assessment will be done on 21 rst day. | 5) Final assessment will be done on 51 rst day | i.e. Dashanga Guggulu will be given for 30 days.
Virechana and Dashang Guggul as Shamana
Time Frame: 1)On zero day i.e. B.T.value | 2)Rukshana Pachana Kvath will be given for 5 | days. | 3)From 6th day Snehapana will be administered | for seven days and assessment will be done on | 13th day. | 4)Virechana will be given on 16 th day and | assessment will be done on 21 rst day. | 5) Final assessment will be done on 51 rst day | i.e. Dashanga Guggulu will be given for 30 days.
lipid profile.
Time Frame: 1)On zero day i.e. B.T.value | 2)Rukshana Pachana Kvath will be given for 5 | days. | 3)From 6th day Snehapana will be administered | for seven days and assessment will be done on | 13th day. | 4)Virechana will be given on 16 th day and | assessment will be done on 21 rst day. | 5) Final assessment will be done on 51 rst day | i.e. Dashanga Guggulu will be given for 30 days.
drug on body mass index, waist hip ratio and
Time Frame: 1)On zero day i.e. B.T.value | 2)Rukshana Pachana Kvath will be given for 5 | days. | 3)From 6th day Snehapana will be administered | for seven days and assessment will be done on | 13th day. | 4)Virechana will be given on 16 th day and | assessment will be done on 21 rst day. | 5) Final assessment will be done on 51 rst day | i.e. Dashanga Guggulu will be given for 30 days.
Secondary Outcomes
- II} Secondary objectives:(1) To review and study literature of Sthaulya.)