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CTRI Number  CTRI/2025/12/098661 [Registered on: 08/12/2025] Trial Registered Prospectively
Last Modified On: 05/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   A study to assess how individualized homoeopathic treatment helps women with hypothyroidism who have irregular menstrual cycles, by evaluating changes in their hormones (FSH and LH). 
Scientific Title of Study   Evaluation of the Effectiveness of Individualized Homoeopathic Medicine on Menstrual Dysfunction in Hypothyroid Women through Hormonal Study of Gonadotrophins (FSH & LH): A Prospective, Open-Label Clinical Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rathod Lavanya 
Designation  Post graduate trainee 
Affiliation  National Institute of Homoeopathy 
Address  OPD-24,Depatment of Practice of Medicine, National Institute of Homoeopathy, Block–GE, Sector-III, Salt Lake, Kolkata

Kolkata
WEST BENGAL
700106
India 
Phone  9493065605  
Fax    
Email  rathodlavanya98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rathod Lavanya 
Designation  Post graduate trainee 
Affiliation  National Institute of Homoeopathy 
Address  OPD No.24,Department of Practice of Medicine, National Institute of Homoeopathy, GE Block, Sector 3,Saltlake, Kolkata. Block–GE, Sector-III, Salt Lake, Kolkata Kolkata WEST BENGAL 700106 India

Kolkata
WEST BENGAL
700106
India 
Phone  9493065605  
Fax    
Email  rathodlavanya98@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Professor Dr Gautam pal 
Designation  Professor and HOD of Practice of Medicine 
Affiliation  National Institute of Homoeopathy 
Address  OPD No.24,Department of Practice of Medicine, National Institute of Homoeopathy, GE Block, Sector 3,Saltlake, Kolkata.
Block–GE, Sector-III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India 
Phone  9433902556  
Fax    
Email  drgautampal@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy,Kolkata 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 Rathod Lavanya  National Institute of Homoeopathy  OPD No.24,Department of Practice of Medicine, National Institute of Homoeopathy, GE Block, Sector 3,Saltlake, Kolkata. Block–GE, Sector-III, Salt Lake, Kolkata Kolkata WEST BENGAL 700106 India
Kolkata
WEST BENGAL 
9493065605

rathodlavanya98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Homeopathy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E038||Other specified hypothyroidism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic medicine   Individualized Homoeopathic medicine will be prescribed in potency appropriate to each patient’s clinical presentation. The medicines will be administered orally, in the form of pills or liquid, as per standard homoeopathic practice. The dose and frequency will vary based on individual patient response and follow-up assessment. The total duration of treatment will be 6 months. 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Biochemically confirmed diagnosis of primary hypothyroidism with Elevated serum TSH with concurrently decreased levels of T4, in women presenting with menstrual dysfunction presenting as any of the following conditions like Amenorrhea, Oligomenorrhea, Menorrhagia, Metrorrhagia, or Epimenorrhea.
2.Females aged 18 to 45 years diagnosed with primary hypothyroidism, under stable thyroxine therapy for at least 3 months, presenting with documented menstrual irregularities.
3.Documented alterations in gonadotropin levels (FSH and or LH), measured between day 2 and day 5 of the menstrual cycle, based on standard laboratory reference ranges.
4.Willingness to participate, with voluntary written informed consent obtained prior to enrolment.
 
 
ExclusionCriteria 
Details  1.Current or recent (within past 3 months) use of oral hormonal contraceptives or hormone replacement therapy.
2.Pregnant or breastfeeding women.
3.Known cases of psychiatric disorders, autoimmune diseases, or serious systemic illnesses (e.g. malignancies, end stage organ failure).
4.Substance abuse or dependency, including alcohol or recreational drugs.
5.Known cases of PCOS with hyperandrogenism, endometriosis, DUB, pelvic inflammatory disease, bleeding disorders, or structural uterine anomalies.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.The effectiveness of individualized Homoeopathic treatment in hypothyroid women with menstrual irregularities will be assessed by comparing menstrual cycle parameters from baseline to end of treatment (6 months), measured using a structured Menstrual Cycle Charting Diary completed by participants.
2.Serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels will be measured at baseline, 3rd month, and 6th month to evaluate hormonal changes in response to treatment.
 
Baseline ,3rd month, after 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Thyroid function parameters including thyroid stimulating hormone, triiodothyronine & thyroxine will be assessed at baseline, at three months & at six months to monitor thyroid status during the intervention.

2. Improvement in menstrual regularity & menstrual pattern will be analysed along with the normalization of hormonal & thyroid profiles at all three assessment points to determine the correlation between biochemical outcomes & symptomatic outcomes. 
Baseline ,3rd month, after 6 months
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   16/12/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

This interventional study aims to evaluate the effectiveness of individualized homoeopathic treatment in managing menstrual dysfunction among women with primary hypothyroidism. Menstrual irregularities assessed include amenorrhea, oligomenorrhoea, menorrhagia, metrorrhagia, and epimenorrhea. The study further examines changes in serum follicle-stimulating hormone  and luteinizing hormone  levels as objective biomarkers of hypothalamic pituitary ovarian  axis regulation under homoeopathic therapy.

Pre and post treatment variations in thyroid profile parameters, including TSH T3 and T4 will also be analyzed to determine any associated improvement in endocrine function. Additionally  the study explores the correlation between biochemical normalization and clinical improvement in menstrual patterns.

Due to the absence of prior interventional evidence in this area, the study proposes an initial sample size of 34 participants.

Inclusion criteria comprise women aged 18 to 45 years with biochemically confirmed primary hypothyroidism, stable on thyroxine therapy for more than 3 months, presenting with menstrual dysfunction and documented FSH and LH alterations measured between cycle days 2 to 5. Participants must provide voluntary written informed consent. Exclusion criteria include pregnancy or lactation, recent use of hormonal contraceptives, systemic or psychiatric illnesses substance abuse and known cases of PCOS with hyperandrogenism endometriosis dysfunctional uterine bleeding pelvic inflammatory disease bleeding disorders  or structural uterine anomalies.

 
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