| CTRI Number |
CTRI/2025/06/088669 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of herbal compositions on body weight, body composition and metabolic health in overweight subjects |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled clinical study to evaluate the effect of herbal compositions CL19183 and CL24212 on body weight, body composition and metabolic health in overweight subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APX/OW/CL24212/25 Protocol Version 02 01-Feb-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anubha Srivastava |
| Designation |
MBBS, MD |
| Affiliation |
Swaroop Rani Hospital, Motilal Nehru Medical College |
| Address |
Room no 31, Ground Floor, Dept. of General Medicine, Swaroop Rani Hospital, Motilal Nehru Medical College MG Road, Prayagraj
Allahabad
UTTAR PRADESH
211002
India |
| Phone |
9453029922 |
| Fax |
|
| Email |
drvarma_anubha@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Golakoti Trimurthulu |
| Designation |
Senior Vice President Technical |
| Affiliation |
LAILA NUTRA PRIVATE LIMITED |
| Address |
D.No.40-15-14,Sudarsan Apartment,Brindavan Colony, Vijayawada (Urban)
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
08666626666 |
| Fax |
08662546216 |
| Email |
drgt@lailanutra.com |
|
Details of Contact Person
Public Query
|
| Name |
Alluri Venkatakrishna Raju |
| Designation |
General Manager |
| Affiliation |
LAILA NUTRA PRIVATE LIMITED |
| Address |
D.No.40-15-14,Sudarsan Apartment,Brindavan Colony, Vijayawada (Urban)
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
08666626666 |
| Fax |
08662546216 |
| Email |
avkr@lailanutra.com |
|
|
Source of Monetary or Material Support
|
| Laila Nutra Private Limited D.No.40-15-14,Sudarsan Apartment,Brindavan Colony,Vijayawada (Urban), Krishna- 520010, Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Apex CPG LLC |
| Address |
300 Brush Creek Road, #804, Warrendale, PA 15095 |
| Type of Sponsor |
Other [Nutraceutical Industry] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Laila Nutra Private Limited |
D.No.40-15-14,Sudarsan Apartment,Brindavan Colony,Vijayawada (Urban), Krishna- 520010, Andhra Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Kiran Kumar |
St Theresa’s Hospital |
Department of General Medicine,OPD Block,Room No 05,Ground Floor,Erragadda Main Rd,opposite Rhythubazar,Sanath Nagar
Hyderabad
TELANGANA |
8008220098
drkiranmacherla@gmail.com |
| Dr Anubha Srivastava |
Swaroop Rani Hospital, Motilal Nehru Medical College |
Dept. of General Medicine, Room No 31, Swaroop Rani Hospital,Motilal Nehru Medical College, M G Road, Prayagraj, 211002
Allahabad
UTTAR PRADESH |
9453029922
drvarma_anubha@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee MLN Medical College |
Approved |
| St Theresa’s Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Over-weight |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CL19183 |
One capsule morning after breakfast with water for 16 weeks |
| Intervention |
CL24212 |
One capsule morning after breakfast with water for 16 weeks |
| Comparator Agent |
Placebo |
One capsule morning after breakfast with water for 16 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy male and female subjects aged between 25-55 years with body mass index (BMI) of 25-29.9 kg/m2.
2.Subjects with sedentary lifestyle, no regular athletic or sports activities.
3.Subjects willing to participate in walking-exercise (5 days a week, 30 min per day) over
study duration.
4.Subjects with normal thyroid hormone profile.
5.Subjects agreed to consume recommended standard diet.
6.Subjects who are willing to abstain from alcohol, coffee, tea, cola, energy drinks &
chocolate for at least 24 hrs. prior to visits and final visit.
7.Subjects who are non-smokers.
8.Subject agrees to maintain diet tracker.
9.Subject considered generally healthy as per health history and routine clinical
investigations during screening.
10..Female subjects of childbearing potential must be using a medically acceptable form of
birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g.,
oral or patch contraceptives, intrauterine device, Depo-Provera®, or double-barrier and have a
negative pregnancy test at the screening visit.
11.Ability to understand the risks/benefits of the protocol and willing to sign the written
informed consent. |
|
| ExclusionCriteria |
| Details |
1.Subjects who were taking medications which affect the metabolic rate (e.g. antidepressants,
beta-blockers, hormones, etc.).
2.Subjects on weight loss practices, usage of weight reduction supplements/nutrition products
will be excluded.
3.Subjects underwent treatment for COVID 19 within last 3 months or tested positive during
the study will be excluded.
4.Subjects participated in any weight loss programs within 3 months.
5.Subjects who are diabetic and/or hypertensive.
6.Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies.
7.Subjects taking medications for or suffering from a medical condition that could impact
results related to metabolism (e.g., thyroid disorders, diabetes, mental disorders such as
anxiety or depression, heart disease, arthritis, cancer).
8.Subjects with HIV Positive.
9.Female subjects, who are pregnant, breast feeding or planning to become pregnant during
the study.
10.Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
11.Any other condition that, in the opinion of the investigator, would adversely affect the
subject’s ability to complete the study or its measures.
12.Use of nutritional supplements (e.g., creatine, protein drinks, amino acids, or vitamins) or
ergogenic aids and caffeinated and not caffeinated thermogenics within 30 days prior to the
study.
13.Subjects who are participated or currently participating in another clinical trial within 30
days prior to screening. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to the end of the study period in Body weight |
Week 0(Baseline),Week 2, Week 4,Week 8,Week 12,Week 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to the end of the study period in Body mass index (BMI) |
Screening, Week 0(Baseline),Week 2, Week 4,Week 8,Week 12,Week 16 |
| Change from baseline to the end of the study period in Body composition using DEXA (including fat and lean mass) |
Week 0(Baseline),Week 8,Week 16 |
Change from baseline to the end of the study period
Waist and Hip circumference (WC & HC) |
Week 0(Baseline),Week 2, Week 4,Week 8,Week 12,Week 16 |
Change from baseline to the end of the study period
Waist to hip ratio (WHR) |
Week 0(Baseline),Week 2, Week 4,Week 8,Week 12,Week 16 |
| Change from baseline to the end of the study period Lipid profile (including Apo B and amyloid A) |
Week 0(Baseline),Week 8,Week 16 |
Change from baseline to the end of the study period Adiponectin,
ghrelin, total glucagon-like peptide 1(GLP-1), C-Peptide, Glucagon,VCAM-1, and ICAM-1 |
Week 0(Baseline),Week 8,Week 16 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
25/06/2025 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The Purpose of the study is to evaluate the efficacy of herbal composition CL19183 and CL24212 on body weight, body composition and metabolic health in overweight subjects. A total of 150 male and female subjects aged between 25 and 55 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either CL19183:450 mg or CL24212:300 mg or Placebo arm at 1:1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast for 16 weeks. Apart from primary and secondary outcomes, the study will also record the vital sign and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the CL19183 and CL24212 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention |