| CTRI Number |
CTRI/2025/01/078919 [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
|
Efficacy of herbal supplement on menstrual symptoms, ovarian morphology and quality of life. |
|
Scientific Title of Study
|
A randomized, double-blind placebo-controlled study to evaluate the efficacy of CL22209 on menstrual symptoms, ovarian morphology and quality of life. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CLS/PMS/CL22209/24 Protocol Version 02 15-Feb-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annavarapu Tirupathi Rao |
| Designation |
Overall Trail 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 Trail 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 |
08662464446 |
| 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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Spoorthi Ramineni |
Akkineni Women’s Hospital |
Department of Endocrinology, Ground Floor, Room No: 01, Dr. No. 54-20/10-12, Srinagar Colony, Bharati Nagar Service Road
Krishna
ANDHRA PRADESH |
08663167336
ctuakkineniwhospital@gmail.com |
| Dr Paipuru Tanuja |
Aster Prime Hospital |
Department of Obstetrics and Gynaecology, Second Floor, Room No: 08, Plot No 4, HMDA Maitrivanam, Satyam Theatre Rd, beside Blue Fox Hotel, Kumar Basti, Srinivasa Nagar, Ameerpet
Hyderabad
TELANGANA |
04049594959
dcr.asterprimehospitals@gmail.com |
| Dr Pinnamaneni Susila |
Samatha Multi Speciality Hospital |
Department of Obstetrics and Gynaecology, First Floor, Room No: 01 D.No.1-605b, Dr. Ramachandra reddy road, G.T. Road, Mangalagiri
Guntur
ANDHRA PRADESH |
9640100800
drpinnamanenisusila@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee - Prime Hospital for Dr Paipuru Tanuja |
Approved |
| Institutional Ethics Committee - NUHA Hospitals for Dr Spoorthi Ramineni |
Approved |
| Latha Super Specialities Hospital Ethics Committee for Dr Pinnamaneni Susila |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pre-Menstrual Symptoms |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
CL22209 |
Dose: 100 mg, Frequency: One capsule a day after breakfast, Route of administration: Oral, Duration: 84 Days |
| Intervention |
CL22209 |
Dose: 50 mg, Frequency: One capsule a day after breakfast, Route of administration: Oral, Duration: 84 Days |
| Comparator Agent |
Placebo |
Frequency: One capsule a day after breakfast, Route of administration: Oral, Duration: 84 Days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Healthy females aged between 25 and 45 years with a Body Mass Index (BMI) of approximately 20 to 29.9 kg/m2.
2.Subjects fulfilling the diagnostic criteria for PMS according to DSM5-TR.(Note: participants who met the above criteria and have experienced the symptoms for at least two consecutive cycles before randomization)
3.Subjects with normal thyroid profile.
4.Subjects who are non-smokers and non-alcohol user.
5.Subject understands the study procedures and provides signed informed consent to participate in the study.
6.Females of childbearing potential who are sexually active must agree to use adequate non-hormonal contraception during the study.
7.Normal vital signs, including electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, hematology, 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 any gynaecological disorders which effects the study indication.
2.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 on a daily basis for any conditions.
3.Subjects who had any hormonal therapy, metformin or any other herbal products in the past 3 months.
4.Hypothyroidism, hyperthyroidism, hyperprolactinemia, Cushings syndrome and congenital adrenal hyperplasia, following a special diet for the past 3 months, taking drugs affecting insulin sensitivity or lipid and hormonal profiles, including glucocorticoids, ovulation-stimulating drugs, anti-obesity, anti-diabetes, anti-hypertensive, anti-estrogenic, anti-androgenic during the last 3 months (except the usual drugs of the subjects).
5.Active gall bladder disease, gynaecological or breast surgery in the last 6 months.
6.Subjects underwent hysterectomy.
7.History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.
8.Pregnant and lactating mothers.
9.History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.
10.History of positive hepatitis, including Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or subjects with human immunodeficiency virus (HIV) and or syphilis.
11.History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
12.Participated in a clinical study with an investigational drug or biologic within the last 60 days.
13.Any condition that in opinion of the investigator, does not justify the subjects participation in the study.
14.Subjects who are being treated for liver cancer or cirrhosis, chronic renal failure, congestive heart failure.
15.Subjects with a systemic disease including tuberculosis, leucosis, collagenosis, multiple sclerosis or other autoimmune diseases.
16.Subjects with a high blood pressure at pre-screening (systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg).
17.Consumption of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or psychiatric drug users.
|
|
|
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:
Total score of PMS using Daily Record of Severity of Problems (DRSP)
|
Menstrual cycles 1, 2, 3, 4, 5 & 6
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Change from baseline to the end of the study period in:
Scores of Depression, Anger and Physical domains of DRSP |
Menstrual cycles 1,2, 3, 4, 5 & 6
|
Change from baseline to the end of the study period in:
Scores of subjective self-assessment on hair quality |
Menstrual cycles 3, 4, 5 & 6 |
Change from baseline to the end of the study period in:
Scores of Global Acne Grading system for acne |
Menstrual cycles 3, 4, 5 & 6 |
Change from baseline to the end of the study period in:
Menstrual distress questionnaire (MDQ) |
Menstrual cycles 3, 4, 5 & 6 |
Change from baseline to the end of the study period in:
Perceived Stress Scale (PSS-10) |
Menstrual cycles 3, 4, 5 & 6 |
| Change from baseline to the end of the study period in: Female Sexual Function Index (FSFI) |
Menstrual cycles 3, 4, 5 & 6 |
Change from baseline to the end of the study period in:
Anthropometric measurements (body weight, waist & hip circumferences) |
Menstrual cycles 3, 4, 5 & 6 |
Change from baseline to the end of the study period in:
Serum FSH, LH, AMH, SHBG, & total testosterone |
Menstrual cycles 3 & 6 |
Change from baseline to the end of the study period in:
Salivary Cortisol |
Menstrual cycles 3 & 6 |
Change from baseline to the end of the study period in:
Serum HOMA-IR & HbA1c |
Menstrual cycles 3 & 6 |
Change from baseline to the end of the study period in:
Ovarian ultrasound scan (total no. of follicles & Antral Follicle Count of dominant ovary) |
Menstrual cycles 3 & 6 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/01/2025 |
| Date of Study Completion (India) |
25/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 efficacy of CL22209 on menstrual symptoms, ovarian morphology and quality of life. A total of 90 female subjects aged between 25 and 45 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 CL22209 - 50 mg or CL22209 - 100 mg or placebo arm at 1:1:1 ratio. The subjects will be instructed to take one capsule a day after breakfast for 84 days. 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 CL22209 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention. |