FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/03/050190 [Registered on: 01/03/2023] Trial Registered Prospectively
Last Modified On: 01/03/2023
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 treatment of painful menses 
Scientific Title of Study   Double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in improving pain of primary dysmenorrhoea in women of reproductive age group 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1288-6370  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sejuti Sarkar 
Designation  Postgraduate Trainee 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept. of Materia Medica, OPD no. PG2 and room no. 4 (Obs-Gyn), 12, Gobinda Khatick Road, Tangra, Kolkata

Kolkata
WEST BENGAL
700046
India 
Phone  7980083978  
Fax    
Email  sejutis95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Saima Shamim 
Designation  Lecturer 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept. of Materia Medica, OPD no. PG2 and room no. 4 (Obs-Gyn), 12, Gobinda Khatick Road, Tangra, Kolkata

Kolkata
WEST BENGAL
700046
India 
Phone  7059526218  
Fax    
Email  drsaima_7@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Saima Shamim 
Designation  Lecturer 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept. of Materia Medica, OPD no. PG2 and room no. 4 (Obs-Gyn), 12, Gobinda Khatick Road, Tangra, Kolkata


WEST BENGAL
700046
India 
Phone  7059526218  
Fax    
Email  drsaima_7@yahoo.com  
 
Source of Monetary or Material Support  
D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046 
 
Primary Sponsor  
Name  D N De Homoeopathic Medical College and Hospital 
Address  12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sejuti Sarkar  D N De Homoeopathic Medical College and Hospital  OPD no. PG2 and room no. 4 (Obs-Gyn), Dept. of Materia Medica, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL 		 7980083978

sejutis95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N944||Primary dysmenorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical-looking placebos plus concomitant care  This group will receive placebos, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Every subject will receive psychological counselling regarding nutritious diet, adequate fluid, maintenance of regimen and hygienic measures and reassurance. Hot water compresses will be advised over the pelvic region at the time of menstrual cramps. Consuming tobacco in any form and alcohol will be advised to avoid. Physical activity will be encouraged and the subjects will be advised to be present for monthly follow-ups. Frequency of administration of the medicine: Once or twice a day as required. Duration of therapy: 3 months. 
Intervention  Individualized homeopathic medicines in centesimal potencies plus concomitant care  Intervention is planned as administering the indicated homeopathic 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. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Every subject will receive psychological counselling regarding nutritious diet, adequate fluid, maintenance of regimen and hygienic measures and reassurance. Hot water compresses will be advised over the pelvic region at the time of menstrual cramps. Consuming tobacco in any form and alcohol will be advised to avoid. Physical activity will be encouraged and the subjects will be advised to be present for monthly follow-ups. Frequency of administration of the medicine: Once or twice a day as required. Duration of therapy: 3 months. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Female patients age between 12 years to 45 years.
2. Patients suffering from PD, pain score of 4-9 on NRS. (ICD-10 code N94.4)
3. Menstrual pain that hampers the day to activity of life.
4. Patients having menstrual pain which may radiate to back or thigh.
5. Female willing to provide a written informed consent voluntarily; illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires 
 
ExclusionCriteria 
Details  1.Patients having any abnormal pelvic pathology in ultrasonography of lower abdomen.
2.Patients undergoing any hormone replacement therapy, using contraceptive pills or history of their use in previous 3months.
3.Patients on NSAIDs therapy for dysmenorrhoea in regular basis.
4.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life and vulnerable population like unconscious, too sick for consultation, differently abled etc.
5.Patient under tobacco chewing and/or smoking, alcoholism and/or any other from(s) of substance abuse and/or dependence.
6.Self-reported immune-compromised state.
7.Patients already undergoing homoeopathic or other system treatment with in last six months.
8.Simultaneous participation in any other clinical trials 
 
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 
0-10 numeric rating scale measuring intensity of pain  Day 1 and day 2 of menstruation for 3 consecutive months 
 
Secondary Outcome  
Outcome  TimePoints 
Dysmenorrhoea Symptom Interference Scale (DSI)  Every month, up to 3 months 
Measure yourself medical outcome profile 2 (MYMOP-2)  Every month, up to 3 months 
Frequency of taking PCM or NSAIDs as rescue remedies  Every month, up to 3 months 
 
Target Sample Size   Total Sample Size="81"
Sample Size from India="81" 
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)   06/03/2023 
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   None yet; to be published later 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. 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.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sejutis95@gmail.com].

  6. For how long will this data be available start date provided 01-11-2024 and end date provided 30-10-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Primary dysmenorrhoea is defined as pain on the lower abdomen or pelvic region without any pelvic pathology that hamper the day-to-day activity of life. Though the use of homoeopathic medicines is prevalent globally to treat the condition, rigorous research evidence in support of homoeopathy in primary dysmenorrhea has remained compromised. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homoeopathic medicines in the treatment of primary dysmenorrhea in women of reproductive age group. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 81 women suffering from primary dysmenorrhea at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by Pain numerical rating scale (NRS) (primary outcome), DSI (Dysmenorrhoea symptom interference scale), MYMOP-2 questionnaire, and frequency of taking paracetamol and/or NSAIDS as rescue remedies (secondary outcomes), every month up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals. 
Close