| CTRI Number |
CTRI/2021/06/033961 [Registered on: 02/06/2021] Trial Registered Prospectively |
| Last Modified On: |
18/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Safety and tolerability study of APRG64. |
|
Scientific Title of Study
|
A prospective, randomized, double-blind, placebo-controlled, parallel clinical study to evaluate the safety and tolerability of single and multiple doses of APRG64 in healthy adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21PR0025-008, Dated 1 April 2021, Version 1.1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Santosh Saklecha |
| Designation |
General Medicine Consultant |
| Affiliation |
Santosh Hospital |
| Address |
Department of General Medicine, 6/1, Promenade Rd, Near Coles Park, Frazer Town, Bangalore, Karnataka
Bangalore
KARNATAKA
560005
India |
| Phone |
9845306703 |
| Fax |
|
| Email |
ssaklecha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jang Yul Kwak |
| Designation |
Director |
| Affiliation |
Syncorp Health Pvt. Ltd |
| Address |
2nd Main Road, Building #06, 3rd Floor. Arekere, Sarvobhogam Nagar. Bangalore 560076. KA INDIA
Bangalore
KARNATAKA
560076
India |
| Phone |
8970888899 |
| Fax |
|
| Email |
deankwak@syncorp.in |
|
Details of Contact Person
Public Query
|
| Name |
Subham Dutta |
| Designation |
Director |
| Affiliation |
Syncorp Health Private Limited |
| Address |
2nd Main Road, Building #06, 3rd Floor. Arekere, Sarvobhogam Nagar. Bangalore 560076. KA INDIA
Bangalore
KARNATAKA
560076
India |
| Phone |
918049788118 |
| Fax |
|
| Email |
subham.dutta@syncorphealth.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GENENCELL CO LTD |
| Address |
Suite #301, UTOWER, 120, Heungdeokjungang-ro, Giheung-gu, Yonginsi, Gyeonggi-do, Korea |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Santosh Saklecha |
Santosh Hospital |
Department of general medicine, #6/1, Promenade Road, Near Coles Park, Frazer Town
Bangalore
KARNATAKA |
9845306703
ssaklecha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Santosh Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers not having any illness of chronic medication. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
APRG64 |
Combination of Agrimonia pilosa L. 50% ethanol extract, Galla rhois 50% ethanol extract.
Dosage: 400 or 800 or 1200 mg/day orally |
| Comparator Agent |
Placebo |
No active ingredient.
Dosage: 400 or 800 or 1200 mg/day orally |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1.Healthy adult males aged 20 - 45 years (both inclusive) of age during the time of screening.
(Medically healthy without clinically significant abnormalities at the screening visit).
2.Subject who has body weight ≥ 60 kg where the weight shall be within ± 20% of the ideal body weight range considering the height of the subject himself.
3.Those who agree to use appropriate contraception and not to donate the sperm during the clinical study period and up to 3 months after the end of the study.
4.Participate voluntarily after listening to the detailed explanation of this clinical trial and fully understand it, and give a written agreement with the cautions of the subject during the clinical trial period.
|
|
| ExclusionCriteria |
| Details |
1.Self- reported history or presence of significant hepatic, renal, neurological, endocrine, hematological, tumor, urinary, cardiovascular, musculoskeletal, and mental diseases, gastrointestinal diseases or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of IP, chronic Hepatitis type B and C, Genetic problems with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.
2.Documented hypersensitivity reaction or anaphylaxis to IP
3.Unfit for screening through a medical examination.
4.Laboratory test results showing Hemoglobin (Hb) more than 13.0 g/dL, AST or ALT more than 3 times of the NUL,total bilirubin more than 1.5 times of NUL,CPK more than 1.5 times of NUL, Estimated Glomerular Filtration Rate less than 60 mL/min/1.73 m2
6.BP outside normal range, a person with a QTcB interval greater than 450ms in a 12-lead ECG test.
7.The use of any medication, alcohol, or drug abuse by urine drug test.
8.Excessive intake of caffeine and alcohol, smoker
9.Received IP from other clinical research study within 90 days prior to administration of IP.
10. Take drugs inducing or inhibiting IP metabolic enzymes.
11.Donated whole blood 60 days prior to administration of IP, or donated component blood within 30 days prior to administration of IP.
12.Consumed grapefruit-containing food within 14 days prior to administration of IP.
13.Consumed any special medicine or herbal medicine that may affect the characteristics of IP within two weeks prior to the first administration date, or taken Over-the-counter drug (OTC) or vitamin supplements within one week prior to the first administration date.
14.Unable to cooperate fully with the requirements of the study protocol.
15.Those who were judged to be ineligible for participation in the clinical study by the investigator due to other reasons.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Number of AE s/ concomitant medication
2.Number of SAEs
3.Physical examination (body examination, height, weight and BMI)
4.Vital signs
5.Clinical laboratory tests (Hematological tests, Blood biochemistry tests, Urine tests)
6.12-lead ECG
|
SAD: Day 1,2,3,8,15
MAD: Day 1,2,3,4,5,6,7,12,19 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/06/2021 |
| Date of Study Completion (India) |
03/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a Randomized, double-blind, and placebo-controlled study. Subjects will be administered one, two, or three tablets as per the assigned Cohort. Study will be conducted in 2 phase: SAD and MAD. |