| CTRI Number |
CTRI/2015/10/006277 [Registered on: 19/10/2015] Trial Registered Prospectively |
| Last Modified On: |
19/10/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Herbal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess effect of oral herbal capsule to improve HDL, DHEA and insulin level. |
|
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 |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SCR/018/EB/2015 Version 1.0 dated 22-Sep-2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonali Ghosh |
| Designation |
Principal Investigator |
| Affiliation |
Spectrum Healthcare |
| Address |
Shop # 10, First Floor, Excel Plaza, Opp. IIT Main Gate, Powai
Mumbai
MAHARASHTRA
400076
India |
| Phone |
02225777755 |
| Fax |
02222846804 |
| Email |
sghosh@spectrumhealthcare.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Ghosh |
| Designation |
Principal Investigator |
| Affiliation |
Spectrum Healthcare |
| Address |
Shop # 10, First Floor, Excel Plaza, Opp. IIT Main Gate, Powai
Mumbai
MAHARASHTRA
400076
India |
| Phone |
02225777755 |
| Fax |
02222846804 |
| Email |
sghosh@spectrumhealthcare.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay Vekariya |
| Designation |
Manager |
| Affiliation |
Spectrum Clinical Research Pvt. Ltd. |
| Address |
401, Kshamalaya Building, 37, New Marine Lines, Mumbai
Mumbai
MAHARASHTRA
400020
India |
| Phone |
02240645100 |
| Fax |
02266155567 |
| Email |
svekariya@spectrumcr.com |
|
|
Source of Monetary or Material Support
|
| Epigeneres Biotech Pvt. Ltd.
2303, Fairfield, ‘A’ Majhiwada Bridge
Thane (West), Thane – 400601 |
|
|
Primary Sponsor
|
| Name |
Spectrum Clinical Research Pvt Ltd |
| Address |
401 - Kshamalaya Building, 37, New Marine Lines, Mumbai - 400020, India |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
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 |
Spectrum Healthcare |
Shop # 10, First Floor, Excel Plaza, Opp. IIT Main Gate, Powai, Mumbai
Mumbai
MAHARASHTRA |
02225777755
02222846804
sghosh@spectrumhealthcare.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ClinXXL Independent Ethics Committee, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Herbal Capsule |
500mg capsule containing herbal extract for oral application, 3 times a day for 30 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 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 |
| Details |
1.Pregnant or lactating women.
2.Subjects with known hypersensitivity to the investigational products.
3.Subjects who have participated in any clinical trial in the past 1 month.
4.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study.
5.Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of treatment on HDL, DHEA and insulin level |
15 and 30 Days from Baseline Visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of treatment on following parameters such as TC, VLDL, LDL, TG, TC/HDL ratio, LDL/HDL ratio, Testosterone, Thrombotic (PT and PTT), renal profile, Homocysteine, Estradiol and AMH |
30 Days from Baseline Visit |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2015 |
| Date of Study Completion (India) |
28/12/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose of this study is to determine effect of capsule containing herbal extract in healthy volunteers.
This is 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.
The study includes only one group. Subject in group will consume capsule containing herbal extract thrice a day for 30 days.
|