| CTRI Number |
CTRI/2024/12/077938 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicines for the complaints before menses |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in the treatment of pre-menstrual syndrome in reproductive women: A double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1316-1134 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravina Sonkar |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Materia Medica, OPD room no. PG2 (MM) and 4 (Gyn-Obs), 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
8777762943 |
| Fax |
|
| Email |
ravinasonkar94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arpita Basu |
| Designation |
Professor |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Materia Medica, OPD room no. PG2 (MM), 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9830273374 |
| Fax |
|
| Email |
drarpitasen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arpita Basu |
| Designation |
Professor |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Materia Medica, OPD room no. PG2 (MM), 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9830273374 |
| Fax |
|
| Email |
drarpitasen@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital,12 Gobinda khatick Road,Kolkata-700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12 Gobinda khatick Road,Kolkata-700046 |
| 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 Ravina Sonkar |
D N De Homoeopathic Medical College and Hospital |
Department of Materia Medica OPD No. PG 2, Gynecology OPD No.4
Kolkata
WEST BENGAL |
8777762943
ravinasonkar94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College and Hospital |
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 |
| Comparator Agent |
Identical-looking placebo plus concomitant care |
This group will be given a placebo that looks exactly like verum. Four No. 40 cane sugar globules moistened with 90% v/v ethanol will make up each dose, which should be taken orally on an empty stomach and clean tongue. The quantity and frequency of administration will be determined by the specific needs of each patient. The supplier of all
other components will be a company accredited by Good Manufacturing Practices (GMP).
The medications and placebos will be repackaged in matching glass bottles, labeled with the name of the medication, its potency, and the code. The random number list will be used to determine how the medications are given. Concomitant care include each participant will receive psychological counseling about maintaining a healthy diet, drinking enough water, adhering to a routine, taking precautions against infections, and feeling reassured. It will be suggested that the subjects participate in physical exercise and show up for monthly follow-ups. Dose: Individualized. Frequency: Individualized. Route of administration: per oral.
Duration of therapy: 3 months. |
| Intervention |
Individualized homoeopathic medicines in individualized dosage and concomitant care. |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH and RADAR software when required with due consultation of Materia Medica. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm.
Concomitant care include each participant will receive psychological counseling about maintaining a healthy diet, drinking enough water, adhering to a routine, taking precautions against infections, and feeling reassured. It will be suggested that the subjects participate in physical exercise and show up for monthly follow-ups.
Dose: Individualized. Frequency: Individualized. Route of administration: per oral. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Diagnosed PMS (ICD 10-N94.3.) as per American College of Obstetrics and Gynaecologists (ACOG) criteria: If the patient reports at least one of the affective and somatic symptoms present during the five days before menses in each of the three previous menstrual cycles.
2.Age 18-40 years.
3.Patients not taking any allopathic treatment or using topical agents for PMS from past 2 weeks will be included in the study.
4.Patients under hormonal replacement therapy (HRT) to be included after a washout period of 3 months.
5.Patients who can read and/or understand either Hindi or English or Bengali. |
|
| ExclusionCriteria |
| Details |
1.Not providing with written informed consent of participation. Unwilling to take part and not giving consent to join the study.
2.Premenstrual dysphoric syndrome (PMDD) state.
3.Irregular cycle, symptoms exist less than 2 cycles.
4.Gynaecological problems, including PCOD, PID, endometriosis, fibroid genital tuberculosis and history of any malignancy etc. on USG.
5.Diagnosed cases of unstable psychiatric illness or other systemic disease like hypertension, heart diseases, diabetes, renal disesase and thyroid disorder affecting quality of life.
6.Planning pregnancy in next 3-4 months.
7.Patients under other medications for any chronic disease.
8.Simultaneous participation in any other clinical trials
9.Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool).
10.Self-reported immune-compromised state, AIDS, hepatitis etc.
11.Undergoing homoeopathic treatment for any chronic disease within last 3 months. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pre-menstrual syndrome scale (PMSS) |
Baseline, and every month, up to 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Premenstrual Tension Syndrome Observer Rating Scale (PMTS-OR) |
Baseline, and every month, up to 3 month |
| Measure Yourself Medical Outcome Profile version-2 (MYMOP-2) |
Baseline, and every month, up to 3 month |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
16/12/2024 |
| 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) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ravinasonkar94@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Premenstrual syndromes are defined as psychological or physical symptoms that appear during the luteal phase of the menstrual cycle, interfere with the person’s regular day to day functioning, and usually go away soon after the onset of menstruation. Premenstrual syndrome (PMS) affects up to 20% of women in their reproductive years and is a major cause of distress and general impairment in everyday life. According to the recent study, the global pooled prevalence of PMS was 47.8%.Previous research conducted in India revealed that 20% of the general population has PMS, and 8% of those who did have severe symptoms. Homoeopathy is frequently used therapy to treat pre-menstrual syndrome; however, the majority of research has remained unpublished or has been published in non-peer reviewed journals. Further research with a larger sample size and objective measures is needed to confirm and enhance the efficacy of individualized homoeopathic medicines (IHMs).This double-blind, randomized, placebo-controlled trial will be an attempt to explore the effects of IHMs in the treatment of premenstrual syndrome in 72 adults. The primary outcome measure is pre-menstrual syndrome scale (PMSS),the secondary outcomes are PMTS-OR,MYMOP-2 questionnaires, all measured at baseline, and every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals. |