| CTRI Number |
CTRI/2022/02/040052 [Registered on: 04/02/2022] Trial Registered Prospectively |
| Last Modified On: |
10/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study on effect of GGE03 in overweight subjects |
|
Scientific Title of Study
|
A prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of
GGE03 on overweight 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 Santosh Saklecha |
| Designation |
Consultant- General Medicine |
| Affiliation |
Santosh Hospital |
| Address |
Department of general medicine, #6/1, Promenade Road, Near
Coles Park, Frazer Town, Bengaluru, Karnataka
Bangalore
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 Private Limited |
| Address |
Building 06, 3rd Floor, 2nd Main Rd, Opposite To British Biologicals
Sarvobhogam Nagar, Arekere, Bengaluru, Karnataka 560076
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 |
Building 06, 3rd Floor, 2nd Main Rd, Opposite To British Biologicals
Sarvobhogam Nagar, Arekere, Bengaluru, Karnataka 560076
Bangalore
KARNATAKA
560076
India |
| Phone |
08049774772 |
| Fax |
|
| Email |
subham.dutta@syncorphealth.com |
|
|
Source of Monetary or Material Support
|
| Research Mentor Co Ltd, #905, SK V1 Tower, 25 Yeonmujang 5 ga-gil, Seongdong-gu, Seoul,
Korea (04782) |
|
|
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, Bengaluru
Bangalore
KARNATAKA |
9845306703
ssaklecha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Santosh Hospital Instutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GGE03 |
Dose: 2 tablets per day (1,600 mg/day, with GGE03 480 mg/day),
with morning meal intake for 12 weeks
Route of administration: Oral |
| Comparator Agent |
Placebo |
Dose: 2 tablets per day with morning meal intake for 12 weeks
Route of administration: Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Volunteers of either sex, between 18 to 60 years (both inclusive) of age.
2. Volunteers of a body mass index (BMI), between 25.00 kg/m2 to 29.99 kg/m2(both inclusive).
3. Subjects who agree the participation in the trial and submit informed consent before the beginning of the trial. |
|
| ExclusionCriteria |
| Details |
1.Known history of hypersensitivity to herbal extracts or dietary supplements.
2.Participated in a commercial weight loss program or clinical trial for obesity/overweight within the last three months.
3.Intentional weight loss of at least 5% within 3 months prior to screening.
4.Any history of surgery such as gastroplasty and intestinal resection, to lose weight within 6 months prior to screening.
5.Consuming drugs or diet foods that affect their weight within 3 months prior to screening.
6.Psychologically significant medical history or current disease (schizophrenia, epilepsy, anorexia, bulimia, etc.), or a history of alcohol or the other drug abuse.
7.Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia in need of treatment), lung disease (chronic obstructive pulmonary disease, etc.) within the last 6 months.
8. Endocrine diseases such as hypothyroidism, PCOD and Cushings syndrom.
9.Fasting blood glucose ≥ 126 mg/dL or random blood glucose ≥ 200 mg/dL, or diabetic patients taking oral hypoglycaemic agents or insulin.
10.Serious dysfunction of liver (alanine and aspartate aminotransferase levels of 2.5 times the upper limit or normal) or kidney (creatinine > 2.0 mg/dL).
11.Signs or symptoms of severe gastrointestinal symptoms such as heartburn and indigestion.
12.Use of drugs (absorbent laxatives and appetite suppressants, health function foods/supplements related to obesity improvement, psychotropic drugs such as anti-depressants, beta-blockers, diuretics, contraceptives, steroids and female hormones) that affect his or her body weight in the last one month or less.
13.Unable to exercise due to musculoskeletal disease.
14.A female who is breastfeeding or pregnant or planning for pregnancy during this study period.
15.Subject judged as unfit for study by PI.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Body fat rate by DEXA (Dual-energy X-ray absorptiometry)
2.Body fat amount by DEXA (Dual-energy X-ray absorptiometry).
|
Baseline and 12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Weight
2.Waist Circumference
3.Hip Circumference
4.Waist to Hip Ratio
5.Body Mass Index (BMI)
6.Lean Mass by DEXA (Dual-energy X-ray absorptiometry)
7.Total Cholesterol
8.HDL-Cholesterol
9.LDL-Cholesterol
10.Triglyceride
11.Visceral Fat Area
12.Subcutaneous Fat Area
13.Total Fat Area
14.Adiponectin |
Baseline and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
14/02/2022 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The rationale of the study is to evaluate the efficacy and safety of GGE03 on overweight subjects. GGE03 is a steamed ginger extract powder which is obtained from Ginger. Ginger is known to have wide variety of medicinal benefits and contains powerful antioxidant, cytoprotective, digestive and antibacterial effects.
This trial is a reconduct of clinical trial registered with the number CTRI/2020/03/024216 with different time points. |