| CTRI Number |
CTRI/2024/01/061102 [Registered on: 03/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study of CQ Extract in Obese subejcts |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of CQ Extract in obese subjects – A Randomized, Double Blind, Multicenter, Placebo Controlled, Comparative, Interventional, Prospective, Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NISARGA CQ OBSTY 2023 2 Version 1.0 27th Nov 2023 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Vineet Kumar Malhotra |
| Designation |
Chief Investigator |
| Affiliation |
Vignaharta Health Care Clinic |
| Address |
Department of Medicine OPD, OPD No. 1, first Floor, Vignaharta Health Care Clinic, Sr.No.15, Mangal Hights, Pune Solapur Road Hadapsar, Pune
Pune
MAHARASHTRA
412308
India |
| Phone |
09404226170 |
| Fax |
|
| Email |
vinekmalhotra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A,B,C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A,B,C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Nisarga Biotech Pvt. Ltd.
275- Chandan Nagar, Addl.
MIDC, Satara -415004,
Maharashtra |
|
|
Primary Sponsor
|
| Name |
Nisarga Biotech Pvt Ltd |
| Address |
275 Chandan Nagar Additional
MIDC Satara 415004
Maharashtra |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nilesh Londhe |
Nirvikar Ayurveda Hospital |
Department of General OPD, OPD No. 1, First Floor, B Wing, Jay Ganesh Samrajya, Pune - Nashik Hwy, Sector No. 3, Bhosari, Pune, Pimpri-Chinchwad, Maharashtra 411039
Pune
MAHARASHTRA |
9881572395
drnileshlondhe@gmail.com |
| Dr Aishwarya Gandas |
Vignaharta Health Care Clinic |
Department of Medicine OPD, OPD No. 1, first Floor, Vignaharta Health Care Clinic, Sr.No.15, Mangal Hights, Pune Solapur Road Hadapsar, Pune
Pune
MAHARASHTRA |
08378857841
aishwaryagandas12@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee, Mhaske Hospital and Research Centre, Hadapsar, Pune. |
Approved |
| Independent Ethics Committee, Nirvikar Ayurveda Hospital Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obesity |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: CQ Extract, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 450(mg), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 120 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | Subjects will be asked to take given product in a dose of 1 capsule twice daily orally after meals with water for 120 days. |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. BMI greater than or equal to 25 Kg meter square and less than or equal to 34.9 Kg meter square
2. Willing to come for regular follow up visits.
|
|
| ExclusionCriteria |
| Details |
1. Intake of over the counter weight loss agents, centrally acting appetite
suppressants or prior surgery for obesity in the previous three months.
2. History of pathophysiologic, genetic syndromes associated with obesity
Cushings syndrome, Turners syndrome, Prader Willi syndrome
3. Alcoholics and subjects with substance abuse
4. Subjects with known malignancy.
5. Subjects having history of coagulopathies, cardiovascular diseases, Asthma.
6. Subjects with Diabetes Mellitus, poorly controlled Hypertension.
7. TSH greater than 10mIU L and T3 and T4 higher than normal range.
8. Pregnant and lactating women
9. Subjects with hepatic and renal failure
10. Subjects on prolonged greater than 6 weeks medication with corticosteroids,
antidepressants, anticholinergics, etc. or any other drugs that may have an
influence on the outcome of the study.
11. Known hypersensitivity to any of the ingredients of CQ extract
12. Other conditions, which in the opinion of the investigators, makes the patient
unsuitable for enrolment or could interfere with his her participation in, and
completion of the protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in body weight in kg and other anthropometric measurements |
Baseline visit, Day 30, Day 60, Day 90, Day 120 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in Lipid profile
2. Change in general wellbeing on general wellbeing scale
3. Changes in appetite, feeling of fullness, desire to eat, urge to eat
4. Change in body shape
5. Global assessment for overall change by investigator and by patient
6. Tolerability of study products by assessing adverse events
7. Change in laboratory parameters
|
Baseline visit, Day 30, Day 60, Day 90, Day 120 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/01/2024 |
| Date of Study Completion (India) |
10/05/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is a randomized, double blind, multicenter, placebo controlled, comparative, interventional, prospective, clinical study to evaluate efficacy and safety of CQ Extract in obese subjects. The study will be carried out in two centers in India. The primary objective of the study will be to assess change in body weight (kg) and other anthropometric measurements. The secondary objectives of the study will be to assess change in lipid profile, change in general wellbeing on general wellbeing scale, changes in appetite, feeling of fullness, desire to eat, urge to eat, change in body shape, global assessment for overall change by investigator and by patient, tolerability of study products by assessing adverse events and change in laboratory parameters on Baseline visit, Day 30, Day 60, Day 90, Day 120 Summary of Results: It can be concluded from the results of the study that CQ extract showed significant reduction in body weight and BMI is healthy obese participants. Sixteen weeks consumption of CQ extract resulted in significant reduction in all the anthropometric parameters including waist circumference, hip circumference, Neck Circumference, Upper mid arm circumference and calf circumference. Body fat percentage, lean body mass, total body water content and basal metabolic rate were significantly reduced with the use of CQ extrcat Safety assessment showed that CQ extract was well tolerated by participants and there were no significant changes in vital parameters and safety laboratory investigations at the end of the study. No adverse effects were reported with the use of CQ extract over a consumption period of 16 weeks. |