Effect of Tulsi (Ocimum Sanctum) on Biochemical Parameters in Young Overweight and Obese Subjects

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: Tulsi(Ocimum sanctum Linn.) capsules

• Registration Number: NCT02681939
• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

Brief Summary

This is a study to investigate the effect of Tulsi (Ocimum sanctum Linn.) on metabolic and biochemical parameters in young overweight and obese subjects. Thirty overweight/obese volunteers will be divided into two groups. The first group will receive no intervention. The second group will be supplemented with one capsule of Tulsi orally every morning and evening in empty stomach for 60 days. The metabolic parameters and liver enzymes will be evaluated before and after the intervention.

Detailed Description

This is a randomized, parallel group, open label pilot study to investigate the effect of Tulsi (Ocimum sanctum Linn.) on metabolic and biochemical parameters in young overweight and obese subjects. Thirty overweight/obese volunteers will be divided into two groups. The first group will receive no intervention. The second group will be supplemented with one capsule of Tulsi orally every morning and evening in empty stomach for 60 days. The metabolic parameters and liver enzymes will be evaluated before and after the intervention.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-15
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Overweight/obese volunteers of both genders from age 17 to 30 years

Exclusion Criteria

• Addiction to tobacco and/or alcohol.
• Not on drugs like fluoroquinolones, anticonvulsants, antihypertensives, corticosteroids, hormonal contraceptives, hypolipidemic agents, anti psychotics, protease inhibitors and isotretinoin.
• Not suffering from liver disease, malabsorption, nephrotic syndrome, thyroid disorder, allergy or any other chronic disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tulsi	Tulsi(Ocimum sanctum Linn.) capsules	One capsule of Tulsi (Ocimum sanctum) orally, every morning and evening in empty stomach for 60 days regularly.

Primary Outcome Measures

Name	Time	Method
Serum lipid profile	60 days

Secondary Outcome Measures

Name	Time	Method
Fasting plasma glucose	60 days
Fasting plasma insulin	60 days
Serum liver enzymes	60 days
Insulin resistance	60 days	Using homeostatic model assessment(HOMA2)
Body mass index	60 days

Trial Locations

Locations (1)

All India Institute of Medical Sciences, Bhubaneswar; 🇮🇳 Bhubaneswar, Odisha, India