| CTRI Number |
CTRI/2025/09/094738 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathy in the Management of Premenstrual syndrome |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicine in The Management of Premenstrual Syndrome in Women of Reproductive Age Group A Prospective, Single arm, 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 Alka Meena |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Nehru Homoeopathic Medical College and Hospital, Block B, Defence Colony, New Delhi, Delhi. 110024
Department of Homoeopathic Materia Medica, Nehru Homoeopathic Medical College and Hospital, Block B, Defence Colony, New Delhi, Delhi. 110024
South
DELHI
110024
India |
| Phone |
7982355174 |
| Fax |
|
| Email |
alkameena1001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annapurna Sarangi |
| Designation |
Professor (Department of Homoeopathic Materia Medica) |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Nehru Homoeopathic Medical College and Hospital, Block B, Defence Colony, New Delhi, Delhi.
Department of Homoeopathic Materia Medica ,Nehru Homoeopathic Medical College and Hospital, Block B, Defence Colony, New Delhi, Delhi.
South
DELHI
110024
India |
| Phone |
9868396627 |
| Fax |
|
| Email |
drannpurna.sarngi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alka Meena |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Nehru Homoeopathic Medical College and Hospital, Block B, Defence Colony, New Delhi, Delhi.110024
Department of Homoeopathic Materia Medica, Nehru Homoeopathic Medical College and Hospital, Block B, Defence Colony, New Delhi, Delhi.110024
South
DELHI
110024
India |
| Phone |
7982355174 |
| Fax |
|
| Email |
alkameena1001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru Homoeopathic Medical College and Hospital, Block B, Defence Colony, New Delhi, Delhi-110024 |
|
|
Primary Sponsor
|
| Name |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Block B, Defence Colony, New Delhi, Delhi-110024 |
| Type of Sponsor |
Government medical college |
|
|
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 Alka Meena |
Nehru Homoeopathic Medical College and Hospital |
Department of Homoeopathic Materia Medica,Nehru Homoeopathic Medical College and Hospital, Block B, Defence Colony, New Delhi, Delhi-110024.
South
DELHI |
7982355174
alkameena1001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nehru Homoeopathic Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N943||Premenstrual tension syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized homoeopathic medicine will be prescribed based on detailed case taking, totality of symptoms and repertorization using suitable software. Potency selection will be individualized and determined based on symptom totality, susceptibilty and clinical condition. Various potency scales including centesimal, decimal and 50 millesimal will be used administered in single or repeated doses as appropriate to case. Dosage single or repeated doses as pe individual requirement, clinical response and homoeopathic principles. 4 Medicated globules of size 30 administered orally. Follow-ups will be scheduled one month for a period of up to 6 months. Duration of Study will be for 1 Year. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1.Women of Reproductive age Group 15 years to 49 years
2.Regular menstrual cycle for 21 to 35 days for at least 3 consecutive months
3.Confirmed Diagnosis of PMS Diagnosis confirmed using at least one of the following
Premenstrual Symptoms Screening Tool with moderate to severe symptoms Or
ACOG criteria 1 or more than 1 affective and 1 or more than 1 somatic symptom in the 5 days before menses, resolving within 4 days of onset, in at least 2 consecutive cycles
4.History of Premenstrual symptoms for at least 3 months
5. Willing and able to provide informed consent
6. Able to read and understand the language of the symptom scales used
7.No Current Hormonal Therapy |
|
| ExclusionCriteria |
| Details |
1.Current Use of Hormonal or Psychotropic Medications
2.History of Clinical Depression, generalized anxiety, bipolar disorder, or other psychiatric illness.
3.Diagnosis of Premenstrual Dysphoric Disorder
4.Other known diagnosed Gynecological Disorders
Presence of conditions like PCOS, endometriosis, uterine fibroids, or PID that may affect or mimic PMS symptoms.
5.Known or previously diagnosed cases of chronic systemic illnesses (such as thyroid disorders, diabetes mellitus, renal, cardiac, or hepatic diseases) based on medical history or current medication records will be excluded.
6.Currently pregnant, planning to conceive, or breastfeeding during the study period.
7.History of alcohol dependence, tobacco use, or drug abuse.
8.Participation in Other Clinical Trials.
9.Individuals with a self-reported immunocompromised state e.g., HIV, ongoing immunosuppressive therapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Premenstrual Symptoms Screening Tool |
PSST will be evaluated at baseline and at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Premenstrual Tension Syndrome Observer Rating Scale |
At baseline and at 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)
|
13/10/2025 |
| 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="0"
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 study aims to evaluate the effectiveness of individualized homoeopathic treatment in women of reproductive age suffering from Premenstrual Syndrome (PMS). PMS, a common psycho-neuro-endocrine disorder, significantly impairs quality of life yet remains underdiagnosed in India due to social stigma and lack of awareness. The study is designed as a prospective, single-arm, open-label clinical trial conducted at Nehru Homoeopathic Medical College, New Delhi, with a sample size of 40 participants meeting defined inclusion and exclusion criteria. Diagnosis and assessment will be done using validated tools – the Premenstrual Symptoms Screening Tool (PSST) and the Premenstrual Tension Syndrome Observer Rating Scale (PMTS-OR). Participants will receive individualized homoeopathic medicines, selected through detailed case-taking, repertorization, and Materia Medica confirmation. Potency and repetition will be tailored to susceptibility and clinical response, with monthly follow-ups over three cycles. The primary outcome is the reduction in PMS severity scores, while secondary outcomes include functional improvement and identification of commonly indicated remedies. |