| CTRI Number |
CTRI/2017/09/009694 [Registered on: 11/09/2017] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effects of nutritional supplementation of extremely active resveratrol (XAR) in healthy human individuals. |
|
Scientific Title of Study
|
A single centre, open label study to assess the safety and efficacy of oral herbal capsule to improve HDL, DHEA and insulin level in healthy volunteers. |
| Trial Acronym |
SSEHH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagar Chhabria |
| Designation |
Vice-President R & D |
| Affiliation |
Epigeneres Biotech Pvt. Ltd. |
| Address |
A-206, Dalamal towers, Free press Journal Marg, Nariman Point, Mumbai
Mumbai
MAHARASHTRA
400021
India |
| Phone |
9869820610 |
| Fax |
|
| Email |
sagar@epigeneres.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sagar Chhabria |
| Designation |
Vice-President R & D |
| Affiliation |
Epigeneres Biotech Pvt. Ltd. |
| Address |
A-206, Dalamal towers, Free press Journal Marg, Nariman Point, Mumbai
Mumbai
MAHARASHTRA
400021
India |
| Phone |
9869820610 |
| Fax |
|
| Email |
sagar@epigeneres.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar Chhabria |
| Designation |
Vice-President R & D |
| Affiliation |
Epigeneres Biotech Pvt. Ltd. |
| Address |
A-206, Dalamal towers, Free press Journal Marg, Nariman Point, Mumbai
Mumbai
MAHARASHTRA
400021
India |
| Phone |
9869820610 |
| Fax |
|
| Email |
sagar@epigeneres.com |
|
|
Source of Monetary or Material Support
|
| Epigeneres Biotech Pvt. Ltd., A-206, Dalamal Towers, Free press Journal Marg, Nariman Point, Mumbai-400021 |
|
|
Primary Sponsor
|
| Name |
Epigeneres Biotech Pvt Ltd |
| Address |
A-206, Dalamal Towers, Free Press Journal Marg, Nariman Point, Mumbai-400021 |
| Type of Sponsor |
Other [Biotechnology Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Epigeneres Biotech Pvt Ltd |
A-206, Dalamal Towers, Free Press Journal Marg, Nariman Point, Mumbai-400021 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonali Ghosh |
National facility for Biopharmaceutical |
Rd Number 32, Matunga, G.N.Khalsa College campus, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA |
8169266943
-
ghoshsonali075@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clin XXL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
XAR ( Extremely active resveratrol) |
Resveratrol 10.5 mg dose
oral, thrice a day for thirty days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy volunteers of age 20 to 55 years of either sex who are not involved in any regular medication or supplementation.
2. Subjects having HDL level, normal, lower and less than lower range at screening visit.
3. Subjects who are willing to give their written informed consent and comply with the protocol requirements. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of XAR Capsule 500mg (containing 10.5 mg of extremely active resveratrol) on HDL, DHEA and insulin level. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the efficacy of XAR Capsule on Total cholesterol, Very Low Density Lipoprotein,
Low density lipoprotein, Triglyceride, Testosterone, Thrombotic, renal profile, Homocysteine, Estradiol and Anti-Mullerian Hormone. The effect of XAR will be analyzed on the expression of stem cell genes and other genes in the peripheral blood cells. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, double-blind, placebo control clinical study to determine the efficacy of XAR TM capsule (extremely active resveratrol) (bearing fssai approval number 11517001000234) 500 mg to regulate the HDL levels in 100 healthy human volunteers. The study will be conducted in India. The primary outcome measures will be HDL, DHEA and insulin levels after 30 days of treatment. The secondary outcomes will be measured on Total cholesterol, Very Low Density Lipoprotein, Low density lipoprotein, Triglyceride, Testosterone, Thrombotic, renal profile, Homocysteine, Estradiol and Anti-Mullerian Hormone. The effect of XAR will be analyzed on the expression of stem cell genes and other genes in the peripheral blood cells
|