Skip to main content
OpenTrials
Completed

NCT Number: NCT02681939

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

17 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

All India Institute of Medical Sciences, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tulsi(Ocimum sanctum Linn.) capsules

Drug

Primary outcomes

  1. Serum lipid profile

    Time frame: 60 days

Secondary outcomes

  1. Fasting plasma glucose

    Time frame: 60 days

  2. Fasting plasma insulin

    Time frame: 60 days

  3. Serum liver enzymes

    Time frame: 60 days

  4. Insulin resistance

    Time frame: 60 days

    Using homeostatic model assessment(HOMA2)

  5. Body mass index

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Official study title

Effect of Supplementation of Tulsi (Ocimum Sanctum Linn.) on Metabolic Parameters and Liver Enzymes in Young Overweight and Obese Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2016
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.