| CTRI Number |
CTRI/2019/10/021611 [Registered on: 14/10/2019] Trial Registered Prospectively |
| Last Modified On: |
07/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the safety of Puremeric in Healthy volunteers |
|
Scientific Title of Study
|
An open label, single arm, prospective clinical study to evaluate safety and tolerability of Puremeric (Standardized extract from Curcuma longa) in healthy subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prithviraj Puwar |
| Designation |
Principal Investigator |
| Affiliation |
Anand Multi Specialty Hospital |
| Address |
Room No:2, Ground Floor, Near IOC Petrol Pump, Gorwa,Vadodara
Vadodara
GUJARAT
390016
India |
| Phone |
|
| Fax |
|
| Email |
drprithvi82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt.Ltd, |
| Address |
No.09. 1st Floor. Mythri legacy. Chelekere main road. Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt.Ltd, |
| Address |
No.09. 1st Floor. Mythri legacy. Chelekere main road. Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidya Herbs (P) Ltd,No. 10, 33rd Main, 16th Cross,JP Nagar, 6th Phase, Bangalore – 560 078 |
|
|
Primary Sponsor
|
| Name |
Vidya Herbs P Ltd |
| Address |
No.10, 33rd Main, 16th Cross,JP Nagar, 6th Phase, Bangalore – 560 078 |
| Type of Sponsor |
Other [Manufactureres of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
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 Prithviraj Puwar |
Anand Multi Specialty Hospital |
Room No:2, Department of Cardiology,Near IOC petrol Pump, Gorwa,
Vadodara
GUJARAT |
886644444
drprithvi82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Anand Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with normal Hematology and Biochemical Parameters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Puremeric |
Puremeric 500mg Capsules orally twice in a day for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects having weight > 50 Kg
2. Subjects who have no evidence of any underlying disease
3. Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test.
4. Must be willing and able to give informed consent and comply with the study procedures
|
|
| ExclusionCriteria |
| Details |
1 Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart, thyroid and liver disease) requiring medical treatment
2 History of
Chronic metabolic disease, Psychiatric illness,Drug abuse, smoking, abuse/addiction to alcohol, Eating disorder such as bulimia or binge eating, Endocrine abnormalities including stable thyroid disease, Cardiovascular surgery History of any major surgery
3 Subjects allergic to herbal products
4 Known HIV or Hepatitis B positive or any other immuno-compromised state
5 Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subject’s safety and preclude trial participation
6 Currently participating or having participated in another clinical trial during the last 1 month prior to the beginning of this study
7. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in liver function parameters from baseline to end of treatment |
Day 0, Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in other Laboratory parameters and Vital Signs |
Day 0, day 90 |
| Incidence of AE/SAEs |
Day 0, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
15/10/2019 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
is an open label, single arm, prospective clinical study. Healthy subjects meeting
all inclusion and no exclusion criteria, after signing a written informed
consent will be enrolled in the study. After passing the eligibility criteria,
subjects will receive Puremeric
(standardized extract from Curcuma longa),
500 mg orally, twice a day for 90 days. The subject will arrive at the study
site in a fasted state and blood samples will be collected for laboratory
assessment. The study will be conducted in 2 visits over a period of 90 days. |