FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/01/078898 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
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 
CLS/OW/CL24212/24 Protocol Version 01 23-Jul-2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Annavarapu Tirupathi Rao  
Designation  Overall Trial Coordinator 
Affiliation  CLS Pvt Ltd 
Address  Department of Pharmacology, Room No-201, First Floor, Aswaraopet

Khammam
TELANGANA
507301
India 
Phone  08662464446  
Fax    
Email  tirupathionline@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Annavarapu Tirupathi Rao  
Designation  Overall Trial Coordinator 
Affiliation  CLS Pvt Ltd 
Address  Department of Pharmacology, Room No-201, First Floor, Aswaraopet

Khammam
TELANGANA
507301
India 
Phone  08662464446  
Fax    
Email  tirupathionline@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr Ajjarapu Srinivasu  
Designation  Manager  
Affiliation  CLS Pvt Ltd 
Address  Department of Sales, Room No-101, Ground Floor, Aswaraopet

Khammam
TELANGANA
507301
India 
Phone  086662464446  
Fax    
Email  asrrvja@gmail.com  
 
Source of Monetary or Material Support  
CLS Pvt Ltd, Aswaraopet,Khammam District, Telangana-507301  
 
Primary Sponsor  
Name  CLS Pvt Ltd 
Address  Aswaraopet, Khammam District, Telangana-507301, India 
Type of Sponsor  Other [Herbal exports] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 Yashwanth  NAKSHATRA HOSPITALS  Department of General Medicine, Room No: 05, Ground Floor, Yadav Nagar Colony, Opp. Swagath Grand Hotel, Alkapuri X Roads
Hyderabad
TELANGANA 		 09652508811

yashwanthmiyyapuram09@gmail.com 
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 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee - St Theresas Hospital for Dr Kiran Kumar  Approved 
Nakshatra Hospital Institutional Ethics Committee for Dr M Yashwanth  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Overweight 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CL19183  450 mg, One capsule daily in the morning after breakfast for 16 Weeks 
Intervention  CL24212  300 mg, One capsule daily in the morning after breakfast for 16 Weeks 
Comparator Agent  Placebo  One capsule daily in the morning after breakfast 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 and Investigator 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 and Week 16  
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline to the end of the study period in:
Body mass index (BMI) 		 Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 and 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 and Week 16 
Change from baseline to the end of the study period in:
Waist and Hip circumference (WC & HC)  		 Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 and Week 16 
Change from baseline to the end of the study period in:
Waist to hip ratio (WHR)  		 Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 and Week 16 
change from baseline to the end of the study period in:
Lipid profile (including ApoB and amyloid A) 		 Week 0 (Baseline), Week 8 and Week 16 
Change from baseline to the end of the study period in:
Adiponectin, ghrelin, total glucagon-like peptide 1(GLP-1), C-Peptide, Glucagon, VCAM-1, and ICAM-1 		 Week 0 (Baseline), Week 8 and 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)   29/01/2025 
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="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Suspended 
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 this study is to evaluate the efficacy of herbal compositions CL19183 and CL24212 on body weight, body composition and metabolic health in overweight subjects. Enrolled subjects will receive CL19183 – 450 mg or CL24212 – 300 mg or placebo capsules.  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 signs and adverse events to evaluate the herbal composition’s 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. 
Close