ObesityPhase 2NCT02681939
Effect of Tulsi (Ocimum Sanctum) on Biochemical Parameters in Young Overweight and Obese Subjects
A Phase 2 study testing Tulsi(Ocimum sanctum Linn.) capsules in people with Obesity, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Tulsi(Ocimum sanctum Linn.) capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2016to Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Overweight/obese volunteers of both genders from age 17 to 30 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences, Bhubaneswar
Bhubaneswar, Odisha, 751019
About this study
Official title: Effect of Supplementation of Tulsi (Ocimum Sanctum Linn.) on Metabolic Parameters and Liver Enzymes 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Tulsi(Ocimum sanctum Linn.) capsules
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tulsi(Ocimum sanctum Linn.) capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| Tulsi | Experimental | One capsule of Tulsi (Ocimum sanctum) orally, every morning and evening in empty stomach for 60 days regularly. Receives: Drug: Tulsi(Ocimum sanctum Linn.) capsules |
| No Tulsi | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum lipid profile
Measured: 60 days
Secondary outcomes (5)
Fasting plasma glucose
Measured: 60 days
Fasting plasma insulin
Measured: 60 days
Serum liver enzymes
Measured: 60 days
Insulin resistance
Using homeostatic model assessment(HOMA2)
Measured: 60 days
Body mass index
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sushil Chandra Mahapatra, All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- Sushil Ch Mahapatra, MBBS, MD, Principal investigator, All India Institute of Medical Sciences, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681939
- Sponsor's protocol ID
- T/IM-NF/Physio/15/04
- Status last verified
- Apr 2016
- First submitted
- 9 Feb 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplementation of Tulsi (Ocimum Sanctum Linn.) on Metabolic Parameters and Liver Enzymes in Young Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT02681939
- Acronym / sponsor ID
- T/IM-NF/Physio/15/04
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tulsi | Experimental | Drug: Tulsi(Ocimum sanctum Linn.) capsulesOne capsule of Tulsi (Ocimum sanctum) orally, every morning and evening in empty stomach for 60 days regularly. |
| No Tulsi | No intervention | –No intervention |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Overweight/obese volunteers of both genders from age 17 to 30 years
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tulsi(Ocimum sanctum Linn.) capsules | Drug | Tulsi |
Primary outcome
Serum lipid profile
Time frame: 60 days
5 secondary outcomes
Fasting plasma glucose
Time frame: 60 days
Fasting plasma insulin
Time frame: 60 days
Serum liver enzymes
Time frame: 60 days
Insulin resistance
Time frame: 60 days
Body mass index
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sushil Ch Mahapatra, MBBS, MD principal investigator
All India Institute of Medical Sciences, Bhubaneswar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tulsi(Ocimum sanctum Linn.) capsules in people with Obesity, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum lipid profile (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.