| CTRI Number |
CTRI/2025/01/078999 [Registered on: 20/01/2025] 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 to improve menstrual discomfort and quality of life. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled study to evaluate the efficacy of CL22205 to improve menstrual discomfort and quality of life. |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| EB/MH/CL22205/24 Protocol Version 03 15-Feb-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varuni B G |
| Designation |
Consultant |
| Affiliation |
Eetho Brands Inc (DBA: Dose) |
| Address |
Department of Research
Clinical division,
Room No.01,
Ground Floor,
164,3rd Cross Hanumanth Nagar.
Bangalore
KARNATAKA
560019
India |
| Phone |
6366292424 |
| Fax |
|
| Email |
vbgresearch24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varuni B G |
| Designation |
Consultant |
| Affiliation |
Eetho Brands Inc (DBA: Dose) |
| Address |
Department of Research
Clinical division,
Room No.01,
Ground Floor,
164,3rd Cross Hanumanth Nagar.
Bangalore
KARNATAKA
560019
India |
| Phone |
6366292424 |
| Fax |
|
| Email |
vbgresearch24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shilpa K |
| Designation |
Research Associate |
| Affiliation |
Eetho Brands Inc (DBA: Dose) |
| Address |
Department of Research
Clinical division,
Room No.G-3,
Ground Floor,
742, Krishnanadi road, 6th Main, Sreenagar.
Bangalore
KARNATAKA
560050
India |
| Phone |
9611934557 |
| Fax |
|
| Email |
shilpakkshilpakk389@gmail.com |
|
|
Source of Monetary or Material Support
|
| Eetho Brands Inc (DBA: Dose), 51 NE 24th St., Suite 206,
Miami, FL 33137, 212-555-0199.
|
|
|
Primary Sponsor
|
| Name |
Eetho Brands Inc (DBA: Dose) |
| Address |
51 NE 24th St., Suite 206, Miami, FL 33137, 212-555-0199. |
| Type of Sponsor |
Other [ Herbal exports] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinoba Dondapati |
Banu Hospital- A Unit of PCRI Hospital Pvt Ltd |
Department of gynecology, Division of OBG, First Floor, Room No: 204, Banu Heights: Before NH 67, NTS Gate, l-53, Srinagar, First Lane, Chinnapadugupadu, Kovur
Nellore
ANDHRA PRADESH |
08622256799
drvinobhadondapati@gmail.com |
| Dr S Sailaja |
Vijaya Super Speciality Hospital |
Department of gynecology, Division of OBG, Ground Floor, Room No: 07, 16-II/41 A, Raghava Cine Complex Road,
Nellore
ANDHRA PRADESH |
08612321828
drssailajavijaya@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| PCRI ETHICS COMMITTEE for Dr. Dondapati Vinobha |
Approved |
| PCRI ETHICS COMMITTEE for Dr. S. Sailaja |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oligomenorrhea |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CL22205 |
200 mg - One capsule a day after breakfast for 135 days |
| Comparator Agent |
Placebo |
One capsule a day after breakfast for 135 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Oligomenorrheic females (Menstrual cycle duration between 36-45 days), aged between 25 and 35 years and with a Body Mass Index (BMI) between 20 to 29.9 kg/m2.
2.Subjects with maximum pain intensity greater than or equal to 40 mm on a 100 mm VAS for at least 2 menstrual cycles before participating in the study.
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 patients).
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 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:
The Menstrual Symptoms Questionnaire (MSQ) scores
|
Menstrual cycle 1, 2, 3 & 4 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change from baseline to the end of the study period in: Ovarian Follicular analysis |
Menstrual cycle 1 & 4 |
Change from baseline to the end of the study period in:
Scores of subjective self-assessment on hair quality |
Menstrual cycle 1, 2, 3 & 4 |
Change from baseline to the end of the study period in:
Scores of Global Acne Grading System for acne |
Menstrual cycle 1, 2, 3 & 4 |
Change from baseline to the end of the study period in:
Menstrual distress questionnaire (MDQ) |
Menstrual cycle 1, 2, 3 & 4 |
Change from baseline to the end of the study period in:
Female Sexual Function Index (FSFI) |
Menstrual cycle 1, 2, 3 & 4 |
Change from baseline to the end of the study period in:
Regularity in menstrual cycles (duration between two menstrual bleedings) |
Menstrual cycle 1, 2, 3 & 4 |
Change from baseline to the end of the study period in:
Serum levels of FSH, LH, AMH, SHBG, total testosterone, 17 beta-Estradiol (E2), Progesterone & Prostaglandin F2 alpha (PGF2 alpha). |
Menstrual cycle 1 & 4 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2025 |
| Date of Study Completion (India) |
19/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
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 CL22205 to improve menstrual discomfort and quality of life in oligomenorrheic female subjects. A total of 80 oligomenorrheic female subjects aged between 25 and 35 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 CL22205 200 mg or placebo arm at 1:1 ratio. The subjects will be instructed to take one capsule a day after breakfast for 135 days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal compositions safety and tolerability. The safety assessment of the CL22205 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention. |