| CTRI Number |
CTRI/2026/01/100568 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Homoeopathy in menstrual complaints/ morbidities in adolescents |
|
Scientific Title of Study
|
Efficacy of Homoeopathy in Menstrual Morbidities in Adolescent School-Going Girls: A Cluster Randomized Placebo Controlled Trial |
| 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 Anupriya |
| Designation |
Research Officer/ Scientist-II |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No. 317,
61-65, Institutional Area, opp. D block, Janakpuri
New Delhi 110058
India
South West
DELHI
110058
India |
| Phone |
919871139304 |
| Fax |
|
| Email |
anupriyaccrh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debadatta Nayak |
| Designation |
Assistant Director (H) & OIC |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health,
Ward No 5, Kurichy Panchayat, Sachivothamapuram PO
Kottayam, Kerala- 686532
India
Kottayam
KERALA
686532
India |
| Phone |
04812436322 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhash Kaushik |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No. 408, Central Council for Research in Homoeopathy, 61-65, Institutional Area, opp. D block, Janakpuri,
New Delhi 110058
India
South West
DELHI
110058
India |
| Phone |
919810788976 |
| Fax |
|
| Email |
subhashccrh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional area, opp. D block, Janakpuri, New Delhi - 110058 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hanuman Ram |
Clinical Research Unit (Homoeopathy), Goa |
Room No. G4, Department- Clinical Research, Old G. M. C. building, Ribandar, Goa 403006
North Goa
GOA |
9462279933
drhrchoudhary@gmail.com |
| Dr Xinix Xavier |
National Homoeopathy Research Institute in Mental Health, Kottayam |
Room No. 116, Department- Homoeopathy, Ward No 5, Kurichy Panchayat, Sachivothamapuram PO, Kottayam, Kerala 686532
Kottayam
KERALA |
7276597881
xinix.homoeopathy@gmail.com |
| Dr Brunda Bezawada |
Regional Research Institute (Homoeopathy) |
Room No. 9, Ground floor, Dr GGH Medical College Campus, Eluru road, Gudivada-521301, Krishna district, AP
Hyderabad
TELANGANA |
9550173744
bezawadabrunda@gmail.com |
| Dr Liyi Karso |
Regional Research Institute for Homoeopathy, Guwahati, |
Room No. 101, Ground Floor, CARI Old Building, (Ayurvedic Campus) Borsajai, P.O. Beltola, Guwahati - 781028
Kamrup
ASSAM |
7628990495
liyikarso@gmail.com |
| Dr Papiya Chanda |
Regional Research Institute of Homoeopathy, Agartala |
Room No. 202, Joy Krishna Kobra Para Road, Khumulong, Jirania Agartala, Tripura (West) 799045
West Tripura
TRIPURA |
9903481166
papiyachanda360@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY, NEW DELHI, CENTRAL ETHICS COMMITTEE |
Approved |
| CLINICAL RESEARCH UNIT (HOMOEOPATHY), GOA, INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| NATIONAL HOMOEOPATHY RESEARCH INSTITUTE IN MENTAL HEALTH, KOTTAYAM,INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
| REGIONAL RESEARCH INSTITUTE (HOMOEOPATHY), GUDIVADA, INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
| REGIONAL RESEARCH INSTITUTE FOR HOMOEOPATHY, GUWAHATI, INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
| REGIONAL RESEARCH INSTITUTE OF HOMOEOPATHY, AGARTALA, ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Menstrual morbidities |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicine + Lifestyle changes |
With regards to intervention, Individualized Homoeopathic Medicine (IHM) (administered orally as four pills per dose) in various potencies shall be prescribed to participant, repeated as required, for 6 months, along with advice on lifestyle changes. |
| Comparator Agent |
Placebo + Lifestyle changes |
Placebo, similar in form of homoeopathic medicine, (administered orally as four pills per dose) along with advice on lifestyle changes, for six months. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
1. Adolescent school-going girls between age group 10-19 years suffering from any menstrual complaint.
2. Only those participants giving assent/informed consent or/and the consent of their parents.
|
|
| ExclusionCriteria |
| Details |
1. Girls in age years less than 10 or greater than 19 years.
2. Girls without assent, informed consent or/and consent from their parents.
3. Known cases of bleeding disorders or those with a history of bleeding disorder.
4. Known case of uncontrolled systemic illness.
5. Known case of gynaecological conditions requiring surgical intervention.
6. Known case of psychiatric disorders.
7. Self-reported immunocompromised cases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptomatic improvement on validated scales like MDQ and aMBQ. |
Monthly for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in KAP and Menstrual Practice Questionnaire score. |
Baseline and end of 6 months |
| Days of absenteeism due to menstrual problems. |
Monthly |
| No. of dropouts from school due to menstrual problems. |
Monthly |
| Burden, intensity (NRS) and duration of symptoms(hrs/days). |
Monthly |
| No. of sick days due to menstrual complaints. |
Monthly |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/01/2026 |
| 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="2"
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
|
Menstrual abnormalities such as amenorrhoea, dysmenorrhoea, premenstrual syndrome, and abnormal uterine bleeding are common causes for which women seek medical advice and are a major reason for absenteeism among school going and working-age females. To address these issues, a cluster-randomized, single-blind, placebo-controlled trial is proposed to assess the efficacy of individualized homoeopathic treatment in managing menstrual problems among adolescent school going girls aged 10–19 years. Participants will receive individualized homoeopathic medicines (administered orally as four pills per dose) or placebo, identical in appearance, along with standardized lifestyle modification advice. The intervention will be continued for a duration of six months. All participants will be provided Information, Education and Communication (IEC) materials to reinforce lifestyle and self-care measures. Primary outcomes include symptomatic improvement on validated scales. Secondary outcomes cover changes in knowledge, attitude, practices, number of sick days, symptom burden, intensity and duration, absenteeism, and dropouts.
|