| 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
|
|
|
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
|
|
|
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. |