| CTRI Number |
CTRI/2025/10/095728 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the Effect of Hormone Balancing Brew on Menstrual Health in Women. |
|
Scientific Title of Study
|
An open label, single arm clinical study evaluating the efficacy and safety of Hormone Balancing Brew alongside lifestyle counselling in women with menstrual irregularity. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/25-26/012 Version: 1.00; dated 28th July 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Digambar Gunjkar |
| Designation |
Principal Investigator |
| Affiliation |
Gunjkar Multispeciality Hospital |
| Address |
First floor, Room No- 01, Plot No 315, Sector No 18, Spine Road, Chikhali, Pune
Pune MAHARASHTRA 411062 India |
| Phone |
8698478984 |
| Fax |
- |
| Email |
drpooja.gunjkarhospital@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Suchita A Mukerji |
| Designation |
Founder |
| Affiliation |
SUCHEETAH HEALTH FOODS PRIVATE LIMITED |
| Address |
6th floor, 605, Makani Centre, Plot No 305, 35th Rd, Near Sejal Jewellers, Bandra West- 400050, Mumbai, Maharashtra
Mumbai MAHARASHTRA 400050 India |
| Phone |
9819955560 |
| Fax |
- |
| Email |
suchita@thebasicswoman.com |
|
Details of Contact Person Public Query
|
| Name |
Suchita A Mukerji |
| Designation |
Founder |
| Affiliation |
SUCHEETAH HEALTH FOODS PRIVATE LIMITED |
| Address |
6th floor, 605, Makani Centre, Plot No 305, 35th Rd, Near Sejal Jewellers, Bandra West- 400050, Mumbai, Maharashtra
Mumbai MAHARASHTRA 400050 India |
| Phone |
9819955560 |
| Fax |
- |
| Email |
suchita@thebasicswoman.com |
|
|
Source of Monetary or Material Support
|
| SUCHEETAH HEALTH FOODS PRIVATE LIMITED
6th floor, 605, Makani Centre, Plot No 305, 35th Rd, Near Sejal Jewellers, Bandra West- 400050, Mumbai, Maharashtra |
|
|
Primary Sponsor
|
| Name |
SUCHEETAH HEALTH FOODS PRIVATE LIMITED |
| Address |
G-2, B/29, RICHA STATE, NEW LINK ROAD, ANDHERI WEST, MUMBAI, Mumbai City, Maharashtra, 400053 |
| Type of Sponsor |
Other [Health Supplement Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja Digambar Gunjkar |
Gunjkar Multispeciality Hospital |
First floor, Room No- 01, Plot No 315, Sector No 18, Spine Road, Chikhali, Pune Pune MAHARASHTRA |
08698478984 - drpooja.gunjkarhospital@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sangvi Multispeciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Irregular menstrual cycle |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hormonal Balancing Brew |
consumed orally, twice daily, in the form of an herbal tea for 90 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Female of age within the range of 18 to 35 years
2. Participants must have irregular menstrual cycles, defined as follows: less than 24 days and/or more than 35 days, or cycle-to-cycle variation greater than 7 days for women aged eighteen to twenty-five years and greater than 9 days (26–41 years) in the past 3 cycles, or at least three missed periods in the past 6 months.
3. No hormonal medication in past 3 months
4. BMI between 19 and 30 kg/m² without any comorbidity
5. Willingness to consume the Hormone Balancing Brew for the entire study period
6. Willingness and ability to comply with the diet and lifestyle recommendations for the entire duration of the study. |
|
| ExclusionCriteria |
| Details |
1. Women using or had used any herbs, dietary supplements, medicines or hormonal therapy that contained estrogenic compounds
2. Use of prescribed medication (antibiotics, steroids, insulin sensitizing drugs, oral contraceptives);
3. Known case of polycystic ovary syndrome (PCOS) or polycystic ovarian disease (PCOD), thyroid dysfunction, endometriosis, uterine fibroids, ovarian cysts or major gynecologic/endocrine disorder
4. Hemoglobin more than 10g/dL history of malignancy, significant renal or hepatic disease
5. History of or known case of eating disorders or major psychiatric illness (eg bipolar, major depression)
6. Current pregnancy, lactation, or intention to conceive during study
7.Participants currently taking any of the following supplements for health maintenance or benefits and not willing to refrain: multivitamin-mineral (MVM), B vitamins, fish oil, Ayurvedic or herbal supplements, nutraceutical supplements, fibre supplements etc.
9. Donated blood within two months before study entry, and must not donate blood during the study duration;
10. Any other history, condition, therapy, or uncontrolled intercurrent and chronic illness which could, in the opinion of the investigator, affect compliance with study requirements
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in menstrual cycle length and variability from baseline (recall based on three retrospective cycles at screening) to study end.
2. Changes in menstrual cycle parameters over the study period.
3. Change in symptoms such as mood swings, fatigue, bloating, acne, sleep disturbances assessed using 4-point Likert scale (0=Not at all, 1=Mild; 2=Moderate; 3=Severe).
4. Change in the severity, duration, and working ability due to menstrual cramps as measured by WaLIDD scores
5. Change in premenstrual symptoms severity by PSST
|
Screening, Day 30, Day 60, and Day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in vital parameters
2. Occurrence of adverse events
3. Compliance and tolerability |
screening, baseline, day 30, day 60, and day 90 |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/10/2025 |
| Date of Study Completion (India) |
27/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Menstrual irregularity is a common gynecological concern affecting women of reproductive age and is often associated with hormonal imbalances, stress, lifestyle factors, and underlying metabolic or endocrine disorders. It manifests as abnormal cycle length, inconsistent bleeding patterns, and associated symptoms such as bloating, mood swings, fatigue, cramps, and acne. While hormonal therapies are commonly used, they are not always well-tolerated for long-term use and may cause undesirable side effects. This has led to increasing interest in evidence-based, plant-derived interventions that are safe, non-hormonal, and align with traditional medicine principles. Hormone Balancing Brew is a polyherbal nutraceutical formulation comprising FSSAI-approved ingredientssuch as Mentha spicata (Spearmint), Withania somnifera (Ashwagandha), Asparagus racemosus (Shatavari), Symplocos racemosa (Lodhra), Saraca asoca (Ashoka), and others. These botanicals have demonstrated hormone-modulating, anti-inflammatory, antispasmodic, and adaptogenic properties. Traditional and preliminary scientific evidence suggests that the formulation may help regulate menstrual cycles, reduce PMS symptoms, and improve quality of life without the adverse effects of synthetic hormonal agents. Pharmacologically, the formulation’s ingredients offer synergistic effects: - Spearmint reduces free testosterone and supports estrogen balance.
- Ashwagandha modulates the HPA axis and reduces cortisol.
- Shatavari and Ashoka support uterine health and smooth muscle relaxation.
- Daruharidra (Berberine) and Cinnamon improve insulin sensitivity and hormonal detoxification.
- Ginger, Peppermint, and Lemongrass provide antispasmodic, anti-inflammatory, and mood-supporting effects.
This study aims to evaluate the clinical efficacy and safety of the Hormone Balancing Brew in women with menstrual irregularities, assessing its effects on cycle regularity, menstrual symptoms, and overall well-being. A structured clinical approach with lifestyle counselling is expected to enhance outcomes and provide robust data to validate its therapeutic potential. |