FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 ingredients such 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.

 [A1]Kindly confirm

 
Close