A Clinical trial to study the effects of two drugs, Gomutra triphala vati and Navaka guggulu in patients of sthoulya who are having overweight and obesity (class one) dividing them in two groups randomly and giving medicines for about one and half months

Phase 2

Not yet recruiting

• Conditions: Overweight. Ayurveda Condition: ATISTHAULYAMÂ (KEVALA-KAPHA),

• Registration Number: CTRI/2022/07/043980
• Lead Sponsor: Dr Prithvi N bhat

Brief Summary

This is a randomized controlled clinical study to evaluate the efficacy of Gomutra Triphala Vati  in the management of sthoulya for a duration of 60 days 60 patients in OPD and IPD of PG studies in Kayachikitsa of Alvas Ayurveda Medical College and hospital , Moodbidri vidyagiri Dakshina Kannada, Karnataka ,India. Assesment will be done based on detailed case proforma adopting standard scoring methods of Subjective and Objective parameters

Pre and Post assesment will be done. Clinical Symptoms will be graded and scores will be given accordingly.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-07-13
• Study Start: 2022-07-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients having BMI ranging from 125 to 29.9 Kg/m2( Over weight ) 230 to 34.9 Kg/m2(Class one Obesity ) Associated with any two of the below mentioned features 1Atikshudha 2Atisweda 3Atinidra 4Alasya/ Utsaha hani 5Atipipasa 6Alpa shwasa 7Daurgandhya 8Chala Sphik ,Udara, Stana 9Subjects who are ready to give written informed consent.

Exclusion Criteria

• 1Subjects who are known case of Diabetes Mellitus, Hypertension, Ischemic Heart Disease or any other Systemic diseases.
• 2Obese patients with known Endocrine Dysfunctions.
• 3Pregnant women and Lactating mothers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of the treatment will be assessed based on detailed case proforma adopting standard scoring methods of subjective parameters such as •Atikshudha	The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Atisweda	The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
and objective parameters such as •Body Weight	The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Waist Hip ratio	The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
pre and post interventional assessment will be done.	The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Atinidra	The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Alasya/ Utsaha hani	The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Atipipasa	The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Alpa shwasa	The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Daurgandhya	The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•Chala Sphik ,Udara, Stana	The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks
•BMI	The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks

Trial Locations

Locations (1)

Alvas Ayurveda Medical College and Hospital; 🇮🇳 Kannada, KARNATAKA, India

Alvas Ayurveda Medical College and Hospital

🇮🇳Kannada, KARNATAKA, India

Dr Prithvi N Bhat

Principal investigator

7349158836

prithvigurumane@gmail.com