| CTRI Number |
CTRI/2019/06/019516 [Registered on: 04/06/2019] Trial Registered Prospectively |
| Last Modified On: |
04/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study of PR/HC/17-18/003 formulation in obese or overweight subjects. |
|
Scientific Title of Study
|
An open label single arm clinical study to evaluate the safety and efficacy of PR/HC/17-18/003 formulation for weight management in obese or overweight patients. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PR/HC/17-18/003 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharad Dhawade |
| Designation |
Ayurvedic Consultant |
| Affiliation |
Lokmanya Medical Research Center |
| Address |
OPD 2, Floor 4
Lokmanya Medical Research Center
314/B Telco road, Chinchwad Pune
Pune
MAHARASHTRA
411033
India |
| Phone |
|
| Fax |
|
| Email |
sharaddhawade123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Payal Gawali |
| Designation |
Manager |
| Affiliation |
Aayush Healthcare |
| Address |
Office no.-D-117,Ground floor, Jai Ganesh Vision, World of mother, Akurdi Pune 411035
Pune
MAHARASHTRA
411035
India |
| Phone |
|
| Fax |
|
| Email |
payalgawali.aayush@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Payal Gawali |
| Designation |
Manager |
| Affiliation |
Aayush Healthcare |
| Address |
Office no.-D-117,Ground floor, Jai Ganesh Vision, World of mother, Akurdi Pune 411035
Pune
MAHARASHTRA
411035
India |
| Phone |
|
| Fax |
|
| Email |
payalgawali.aayush@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aayush Healthcare
Office no.-D-117,Ground floor, Jai Ganesh Vision, World of mother, Akurdi Pune 411035 |
|
|
Primary Sponsor
|
| Name |
Aayush Healthcare |
| Address |
D-117,Jai Ganesh Vision, World of mother, Akurdi Pune 411035 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Ms Varsha Bachkar |
Lokmanya Medical Research Centre |
OPD 2, Floor 4, Lokmanya Medical Resaerch Centre, 314/B Telco Road, Chinchwad, Pune
Pune
MAHARASHTRA |
8446623333
bachkarvarsha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight or obese |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
PR/HC/17-18/003 capsules |
2 capsules twice a day before meal for three months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Male and or female patients.
2 Age between 20 to 50 years.
3 BMI between 25 to 40 kg/m2.
4 Willing to come for regular follow-up visits.
5 Able to give written informed consent. |
|
| ExclusionCriteria |
| Details |
1 Intake of over the counter weight loss agents, centrally acting
appetite suppressants in the previous six months.
2 Pathophysiologic/ genetic syndromes associated with obesity
(Cushing’s syndrome, Turner’s syndrome, Praderwilli syndrome).
3 Patients with evidence of malignancy.
4 Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%).
5 Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg).
6 Patients on prolonged (> 6 weeks) medication with corticosteoids,
antidepressants, anticholinergics, etc. or any other drugs that may
have an influence on the outcome of the study.
7 Symptomatic patient with clinical evidence of Heart failure.
8 Patients with concurrent serious hepatic disorder (defined as
Aspartate Amino
Transferase (AST) and / or Alanine Amino Transferase (ALT), Total
Bilirubin,Alkaline Phosphatase (ALP) > 2 times upper normal limit) or
Renal Disorders (defined as S.Creatinine>1.2mg/dL), Severe
Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or
Chronic Obstructive Pulmonary Disease [COPD]), or any other
condition that may jeopardize the study.
9 History of HIV and other viral infections.
10 Alcoholics and/or drug abusers.
11 Prior surgical therapy for obesity.
12 History of hypersensitivity to any of the herbal extracts or dietary
supplement.
13 Pregnant / lactating woman.
14 Patients who have completed participation in any other clinical
trial during the past six (06) months.
15 Any other condition which the Principal Investigator thinks may
jeopardize the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of Body weight
Reduction of BMI
Improved anthropometric measurements (waist circumference, waist: hip ratio)
Lipid profile
Change in leptin & CRP level
QOL Questionnaire
|
Baseline, Day 30,Day 60 and Day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety and Tolerability
Adverse events (AEs), frequency and severity.
Changes in the vital parameters
|
Baseline, Day 30,Day 60 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/06/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An open label single arm clinical study to evaluate the safety and efficacy of PR/HC/17-18/003 formulation for weight management in obese or overweight subjects. The efficacy outcomes include decrease in body weight
and body mass index, change in anthropometric parameters , change in leptin and CRP levels, decrease
in Total Cholesterol, LDL Cholesterol, VLDL Cholesterol and Triglycerides, increase in HDL
Cholesterol, . Safety outcomes for the study involve adverse and serious adverse
events, vital signs and laboratory investigations. |