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Clinical Evaluation of Safety & Efficacy of DRF/AY/4024-A Polyherbal Ayurvedic Formulation for Obesity

A Double Blind Placebo Controlled Randomized Clinical Study to Evaluate The Efficacy Of DRF/Ay/4024 -A Polyherbal Ayurvedic Formulation in Obesity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010888
Enrollment
180
Registered
2017-12-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E660- Obesity due to excess calories

Interventions

Intervention1: DRF/AY/4024 manufactured by Dabur: Amla, Bahera, Haritaki, Pippali (Long), Vidanga, Mustak. Subject was asked to take two tablet orally three times a dayfor 12 weeks Control Interventio

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Obese patients of either sex with BMI 30 to 50 kg/m2 in the age group 18- 50 years. 2. Willingness to sign informed consent and to come for regular follow- up examinations as & when required.

Exclusion criteria

Exclusion criteria: 1. Patients with serious systemic ailments, like Uncontrolled Hypertension, OM, 2. Patients with endocrine obesity, i.e., obesity associated with Cushing Syndrome, thyroid dysfunction etc. 3. Pregnant or lactating females and females who are planning to get conceived in near future. 4. Patients with renal or liver dysfunction. 5. Patients not willing to sign informed consent 6. Patients not willing to come for follow-up when required 7. Patients on steroids or any other chronic medication ( >60 days) for any serious systemic disease.

Design outcomes

Primary

MeasureTime frame
Reduction in weight, BMI, waist circumference over a period of 12 monthsTimepoint: 1 year

Secondary

MeasureTime frame
Reductions in hip circumference, waist to hip circumference, Skin fold and sub-scapular foldsTimepoint: 1 year

Countries

India

Contacts

Public ContactDr Arun Gupta

Dabur India Limited

arun.gupta@dabur.com01203378614

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026