Back to resultsEffect of Tulsi (Ocimum Sanctum) on Biochemical Parameters in Young Overweight and Obese Subjects
Primary Purpose
Obesity
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Tulsi(Ocimum sanctum Linn.) capsules
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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.
Sites / Locations
- All India Institute of Medical Sciences, Bhubaneswar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tulsi
No Tulsi
Arm Description
One capsule of Tulsi (Ocimum sanctum) orally, every morning and evening in empty stomach for 60 days regularly.
No intervention
Outcomes
Primary Outcome Measures
Serum lipid profile
Secondary Outcome Measures
Fasting plasma glucose
Fasting plasma insulin
Serum liver enzymes
Insulin resistance
Using homeostatic model assessment(HOMA2)
Body mass index
Full Information
NCT ID
NCT02681939
First Posted
February 9, 2016
Last Updated
April 18, 2016
Sponsor
All India Institute of Medical Sciences, Bhubaneswar
1. Study Identification
Unique Protocol Identification Number
NCT02681939
Brief Title
Effect of Tulsi (Ocimum Sanctum) on Biochemical Parameters in Young Overweight and Obese Subjects
Official Title
Effect of Supplementation of Tulsi (Ocimum Sanctum Linn.) on Metabolic Parameters and Liver Enzymes in Young Overweight and Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, Bhubaneswar
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tulsi
Arm Type
Experimental
Arm Description
One capsule of Tulsi (Ocimum sanctum) orally, every morning and evening in empty stomach for 60 days regularly.
Arm Title
No Tulsi
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Tulsi(Ocimum sanctum Linn.) capsules
Primary Outcome Measure Information:
Title
Serum lipid profile
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Fasting plasma glucose
Time Frame
60 days
Title
Fasting plasma insulin
Time Frame
60 days
Title
Serum liver enzymes
Time Frame
60 days
Title
Insulin resistance
Description
Using homeostatic model assessment(HOMA2)
Time Frame
60 days
Title
Body mass index
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sushil Ch Mahapatra, MBBS, MD
Organizational Affiliation
All India Institute of Medical Sciences, Bhubaneswar
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences, Bhubaneswar
City
Bhubaneswar
State/Province
Odisha
ZIP/Postal Code
751019
Country
India
12. IPD Sharing Statement
Learn more about this trial
Effect of Tulsi (Ocimum Sanctum) on Biochemical Parameters in Young Overweight and Obese Subjects
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