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CTRI Number  CTRI/2025/08/093452 [Registered on: 22/08/2025] Trial Registered Prospectively
Last Modified On: 28/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of herbal supplement on vasomotor symptoms in Women during Perimenopause 
Scientific Title of Study   The Effects of CL25216 on vasomotor symptoms in women during Perimenopause: a randomised, double-blind, placebo-controlled study 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
APX/VMS/CL25216/25 Version 03 02-Sep-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Prason Kumar J  
Designation  Overall Trial Coordinator  
Affiliation  Laila Nutra Private Limited  
Address  First Floor, R&D Division, Clinical Research Department, Survey No. 181/2,181/3,181/4B, JRD Tata Industrial Estate, Kanuru, Vijayawada.

Krishna
ANDHRA PRADESH
520010
India 
Phone  08666636666  
Fax  08662475278   
Email  prason@lailanutra.in   
 
Details of Contact Person
Scientific Query  
Name  Dr Golakoti Trimurthulu 
Designation  Senior Vice President Technical 
Affiliation  Laila Nutra Private Limited 
Address  Ground Floor, R&D Division, Survey No. 181/2,181/3,181/4B, JRD Tata Industrial Estate, Kanuru, Vijayawada.

Krishna
ANDHRA PRADESH
520010
India 
Phone  08666636666  
Fax  08662546216  
Email  drgt@lailanutra.in  
 
Details of Contact Person
Public Query  
Name  Mr Prason Kumar J 
Designation  Manager-Clinical Research  
Affiliation  Laila Nutra Private Limited 
Address  First Floor, R&D Division, Clinical Research Department, Survey No. 181/2,181/3,181/4B, JRD Tata Industrial Estate, Kanuru, Vijayawada.

Krishna
ANDHRA PRADESH
520010
India 
Phone  08666636666  
Fax  08662546216  
Email  prason@lailanutra.in  
 
Source of Monetary or Material Support  
Laila Nutra Private Limited D.No.40-15-14, Sudarshan Apartments, 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, Sudarshan Apartments, Brindavan Colony, Vijayawada (Urban), Krishna- 520010, Andhra Pradesh 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr B Ratnasri  SHREE Hospitals  Department of Gynecology, First Floor, Room No 02, D.No: 43, 106/ 1-7C/2, Ajith Singh Nagar, Vijayawada.
Krishna
ANDHRA PRADESH 		 9948024196

ctushreehospital@gmail.com 
Dr Amulya Yalamanchi  Yalamanchi Hospitals and research Centres Pvt. Ltd  Department of Endocrinology, First Floor, Room No 01, D. No. 29-7-44, Venkataratnam Street, Suryaraopet, Vijayawada
Krishna
ANDHRA PRADESH 		 08662431220

amulya.yalamanchi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee - Akkineni Womens Hospital for Dr B. Ratna Sri  Approved 
Yalamanchi Hospital Ethics Committee for Dr Amulya Yalamanchi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Participants with Vasomotor Symptoms 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CL25216  250 mg, One capsule a day after breakfast for 105 days 
Comparator Agent  Placebo  One capsule a day after breakfast for 105 days 
 
Inclusion Criteria
Modification(s)  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1.Healthy overweight women (BMI: 25-29 kg/m2) aged between 40 to 55 years with reports of changes in their menstrual cycle for at least 3 months.
2.Participants needed to have a total score of greater than 16 on the Greene Climacteric Scale (GCS), have an intact uterus and ovaries.
3.Early Perimenopausal Women according ‘The Stages of Reproductive Aging Workshop (STRAW) Classification (-2)’ irregular periods without skipping menstrual cycles and more than seven days difference in length of consecutive cycles.
4.Subjects with serum FSH >20 U/L on 3-5 days of menstrual cycle.
5.Subjects with normal pelvic TVS and breast mammogram.
6.Subjects with normal fasting blood glucose level (<125 mg/dl).
7.Subject understands the study procedures and provides signed informed consent to participate in the study.
8.Subjects with normal blood thyroid profile.
9.Females of childbearing potential who are sexually active must agree to use adequate non-hormonal contraception and can neither be pregnant nor lactating from screening throughout the duration of the study.
10.Clinical screening including vital signs, electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, haematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
 
 
ExclusionCriteria 
Details  1.History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years, on anti-coagulant or anti-platelet drugs daily for any conditions.
2.Subjects who had received hormonal treatment or any other herbal products in the previous 6 months.
3.Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
4.Subjects diagnosed with ovarian cysts greater than or equal to 4 cm or any underlying pathology in pelvic transvaginal sonography (TVS) performed during screening.
5.Chronic or acute life stressors relating to a major life change, experiencing depression and/or receiving medication for such illness or disorders, receiving statins or other drugs known to impact on steroid hormone levels.
6.Subjects having active gall bladder disease, gynaecological or breast surgery in the last 6 months.
7.History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.
8.Subjects with abnormal ECG.
9.Pregnant and breast feeding female.
10.History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.
11.Donation/loss of blood 1 unit or 350 mL within 90 days prior to receiving the first dose of study medication.
12.Use of any recreational drugs (cocaine, amphetamine, barbiturates, benzodiazepines, cannabinoids, and morphine).
13.History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
14.Participated in a clinical study with an investigational drug or biologic within the last 30 days.
15.Any condition that in opinion of the investigator, does not justify the subjects’ participation in the study.
16.Subjects with a high blood pressure at screening (systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 100 mmHg).
17.Subjects with progressive systemic diseases (e.g. tuberculosis, leucosis, collagenosis, multiple sclerosis, AIDS, HIV infections, Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or other auto-immune diseases).
18.Evidence or history of clinically significant (in the judgment of the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
19.High alcohol intake (greater than 2 standard drinks per day), smokers (greater than 5 cigarettes per day).
 
 
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: Scores of Greene Climacteric Scale (GCS)
 		 Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days) 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline to the end of the study period in:
GCS sub-scale (psychological symptoms, somatic/physical symptoms, and vasomotor symptoms.) scores 		 Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days) 
Change from baseline to the end of the study period in: Resting Metabolic Rate (RMR)   Day 1 and Day 105 (±10 days) 
Change from baseline to the end of the study period in: Positive and Negative Affect Schedule (PANAS-X) scores  Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days) 
Change from baseline to the end of the study period in: Quality of life questionnaire (Short Form -36)  Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days) 
Change from baseline to the end of the study period in Sexual Function: Female Sexual Function Index (FSFI)   Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days) 
Change from baseline to the end of the study period in: The Hot Flush Weekly Weighted Score (HFWWS)  Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days) 
Change from baseline to the end of the study period in: Bodyweight and BMI   Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days) 
Change from baseline to the end of the study period in: Scores of subjective self-assessments on hair quality  Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days) 
Change from baseline to the end of the study period in: Skin wrinkle assessment  Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days) 
Change from baseline to the end of the study period in: Subject’s self-assessment of skin Questionnaire  Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days) 
Change from baseline to the end of the study period in: Serum biomarkers (lipids, HOMA-IR, FSH, LH, 17 beta-estradiol and AMH)  Day 1 and Day 105 (±10 days) 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   30/08/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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)  

The purpose of this study is to evaluate the effects of CL25216 on vasomotor symptoms in women during perimenopause. A total of 80 female aged between 40-55 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 CL25216 – 250 mg or placebo arms at 1:1 ratio. The subjects will be instructed to take one capsule a day after breakfast for 105 days. Apart from primary and secondary outcomes, the study will also record the vital signs, adverse events, Breast mammogram and endometrial thickness using Transvaginal Scan. to evaluate the herbal composition safety and tolerability. The safety assessment of the CL25216 will also include routine laboratory investigations on blood, urine and clinical chemistry at Screening/Randomisation visit and the final visit of the intervention.


 
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