Effect Of Haritaki and Dhanvayas in the Management Of Obesity

Phase 2

• Conditions: Health Condition 1: E669- Obesity, unspecified

• Registration Number: CTRI/2023/11/059848
• Lead Sponsor: Ayurvedic and Unani Tibbia College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients between the age group of 18-60 years of either sex.

2. Willing and able to participate in the study for 90 days.

3. BMI >30.00kg/m2 and BMI < 40 kg/m2.

4. Patient not taking any oral conventional medicine.

5. Patients having associated symptoms according to Ayurvedic classification of

Sthaulya (Obesity) like Chalsphikudarstana, Swedadhikya, Atiskhudha,

KshudraSwasa, Angagaurava , Anga Chalatva ,Atipipasa, Avyavaya.

Exclusion Criteria

1. The patient having B.M.I. >40.

2. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,

Myocardial Infarction, congestive heart failure, Stroke or severe Arrhythmia,

Unstable angina in the last six months.

3. Patients on prolonged ( >6weeks) medication with corticosteroids, antidepressants,

anticholinergics, immunosuppressant, estrogen replacement therapy etc. or anyother drugs that may have an influence on the outcome of the study and patientson oral contraceptives.

4. Patients with poorly controlled hypertension (systolic >140 and diastolic >90 mmof Hg) despite of antihypertensive agents.

5. .Patients having history of diabetes i.e (HbA1c > 6.5%)

6. Hypothyroidism .

7. Pregnancy and Lactating mother.

8. Patient who has participated in any clinical trial in past 6 Months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparative evalauation of Both the drug i.e. Haritaki churna and Dhanvyas churna would be assessed on -disappearance of clinical symptoms of sthaulya as per questionaire and improvement in Lipid Profile of subjects, BMI,Subjective/Objective parameters , Girth measurements asfrom baseline and after 90 days of therapyTimepoint: 3 months

Secondary Outcome Measures

Name	Time	Method
Pharmacognostical and Phytochemical evalaution of the drug would be done from GMP certifiedlab. <br/ ><br>Improvement in Health conditions as per SF-36 Health survey. <br/ ><br> At the end of the study,Safety of drug can be noted with any adverse effect and the five -point Global Assessment scale for efficacy(very much improved,much impoved,Improved,Mildly improved,worse) will be usedTimepoint: 3 months