| CTRI Number |
CTRI/2018/04/013157 [Registered on: 10/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
02/04/2018 |
| 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 to assess the safety and efficacy of capsifen in a weight management study |
|
Scientific Title of Study
|
A randomised placebo-controlled clinical study to assess the safety and tolerability of Capsifen and its efficacy on energy expenditure |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mala K N |
| Designation |
Principal Investigator |
| Affiliation |
Sri Rama Hospital |
| Address |
Room No:1, Ground Floor,Fort Complex Fort Road, Opposite to Rajkamal Theater doddaballapur
Bangalore
KARNATAKA
561203
India |
| Phone |
|
| Fax |
|
| Email |
malakn.srhospital@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnakumar I M |
| Designation |
General Manager R and D |
| Affiliation |
Akay Flavours and Aromatics Private Limited |
| Address |
Resrach and Development Building, Ist Floor Malaidamthuruthu, Ernakulam
Ernakulam
KERALA
683561
India |
| Phone |
|
| Fax |
|
| Email |
Krishnakumar.IM@akay-group.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Private Limited |
| Address |
No 9 Myhthri Legacy Ist Floor Chelekere Main Road Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akay Flavours and Aromatics Private Limited ,Malaidamthuruthu ,Ernakulam KERALA ,683561 India |
|
|
Primary Sponsor
|
| Name |
Akay Flavours and Aromatics Private Limited |
| Address |
Malaidamthuruthu ,Ernakulam KERALA ,683561 India |
| Type of Sponsor |
Other [Manufacturer 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 Mala K N |
Sri Rama Hospital |
Room N0.1, Ground Floor, Fort Complex Fort Road, Opposite to Rajkamal Theater doddaballapur
Bangalore
KARNATAKA |
984500818
malakn.srhospital@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Rama Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Body Mass Index Between 27 - 40 Kg/m |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capsifen |
200mg capsules once everyday for 56 days |
| Comparator Agent |
Placebo |
200mg capsules once everyday for 56 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Male or female healthy volunteers who have been practicing exercise or training
sessions for a minimum period of last 1 month to manage the obesity
2) Age 21-40 Years ( Both Inclusive)
3) Subjects with Body Mass Index (BMI) between 27Kg/m to 40 Kg/m
4) Shall agree to sign an Informed Consent Document
|
|
| ExclusionCriteria |
| Details |
1) Subject with history of cardiovascular, Type 2 Diabetes mellitus, pulmonary, hepatic, gastrointestinal problems, and renal problems
2) Subjects with a history of anorexia nevosa or other eating disorders
3) Subjects with known history of gastrointestinal irregularities
4) Prior use of anti obesity agents
5) History of surgical therapy for obesity
6) Subjects with known genetical syndromes which cause obesity
7) Subjects who are currently under any kind of long term medication
8) Subjects with a known allergy to herbal products
9) Subjects with abnormal biochemical or haematological values
10) Pregnant or Lactating Women
11) Any condition that in Opinion of the Investigator, does not justify the Subjects’ participation in the study.
|
|
|
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 Energy Expenditure in comparison with baseline values |
Day 0, Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tolerabily, safety and adverse event assessment |
Day 0, Day 28, Day 56 |
| Change in Biochemical Markers in comparison with basline values |
Day 0, Day 56 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
27/09/2017 |
| 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="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 a randomised placebo-controlled clinical
study. Healthy male and female
volunteers with age between 21- 40 and BMI between 27kg/m to 40kh/m will be enrolled in the study. All the
volunteers should have practicing some kind of exercise at least for the last
one month to manage the obesity or weight. This study will include four visits
(Screening, Day 0, Day 28 and Day 56). During the screening, inclusion
exclusion criteria for the subject are evaluated. All the safety and efficacy
parameters values are collected before dispensing the investigational product
to the volunteer’s on day 0 and that will consider as the Baseline value.
Energy expenditure will be calculated by indirect colorimetric method. Subjects
are requested to come 12 hours fasting for the indirect colorimetric
assessment. All the volunteers are requested to consume a single dose of
placebo or Capsifen (200mg) for a period of 56 days. Safety analysis will be
performed on day 28 and day 56 and all the efficacy parameters will be
evaluated at the end of the study (Day 56 ). The safety and efficacy of
capsifen will be established by comparison of day 56 values with baseline
values |