Clinical study on anal administration of drugs (basti) along with oral medicine in the management of obesity

Phase 2

Not yet recruiting

• Conditions: obesity

• Registration Number: CTRI/2017/08/009215
• Lead Sponsor: National Insytitute of Ayurveda

Brief Summary

This study is a randomized open label parallel group trial comparing the efficacy of Lekhan basti (~medicated enema for obesity) which will be given in Kala basti manner for 15 days of  Anuvasana basti(medicated oily enema) with Triphaladi taila (oil) and Saindhav lavan (rock salt) in the total dose of 120 ml and Asthapana basti with Triphala vidangadi kwath (decoction),Triphaladi oil,honey and Kalka(paste of medicinal drugs) in the total dose of 960 ml in one group of 15 patients and Vidangadi Ghan Vati in another group of 15 patients suffered from obesity. The trial will be conducted in National institute of Ayurveda Jaipur India with primary outcome of reduction in BMI, Hip circumference,waist circumference,mid thigh and mid arm circumference and skin fold thickness.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-09
• Last Update Posted: 2017-07-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1.Age Between 16-70 years, suffering from Sthoulya (Obesity) irrespective of religion, sex, occupation etc.
• 2.Patients who fulfil the criteria for sthoulya & Obesity.
• 3.Patients who are fit for Lekhana Basti karma.
• 4.Patient who are not on any other medicine for Sthoulya Â.

Exclusion Criteria

• 1.Patients with long term Steroid treatment.
• 2.Patients suffering from obesity due to hereditary indisposition.
• 3.Patients with severe Hypertension.
• 5.Patients with Diabetes mellitus.
• 7.Patients who are unfit for Lekhana Basti karma.
• 8.Patients who have any severe metabolic disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Waist circumference,	2 months | Â
BMI,	2 months | Â
Hip circumference,	2 months | Â
Skin fold thickness	2 months | Â
Mid thigh circumference,	2 months | Â
Mid arm circumference.	2 months | Â
Â	2 months | Â

Secondary Outcome Measures

Name	Time	Method
Quality of lifeÂ	2 month

Trial Locations

Locations (1)

National Institute of Ayurveda; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute of Ayurveda

🇮🇳Jaipur, RAJASTHAN, India

Dr Sarvesh Kumar Singh

Principal investigator

8739860237

sarveshksingh21@gmail.com