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

NCT ID: NCT02681939

Last Updated: 2016-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tulsi

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

Group Type EXPERIMENTAL

Tulsi(Ocimum sanctum Linn.) capsules

Intervention Type DRUG

No Tulsi

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tulsi(Ocimum sanctum Linn.) capsules

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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All India Institute of Medical Sciences, Bhubaneswar

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sushil Chandra Mahapatra

Professor and Head, Department of Physiology, All India Institute of Medical Sciences, Bhubaneswar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sushil Ch Mahapatra, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences, Bhubaneswar

Locations

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All India Institute of Medical Sciences, Bhubaneswar

Bhubaneswar, Odisha, India

Site Status

Countries

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India

Other Identifiers

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T/IM-NF/Physio/15/04

Identifier Type: -

Identifier Source: org_study_id

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