| CTRI Number |
CTRI/2024/05/067953 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic Treatment of Primary Dysmenorrhoea. |
|
Scientific Title of Study
|
The Efficacy of Individualized Homoeopathic medicines in Treatment of Primary Dysmenorrhoea:A Double Blind, 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 Debashis Biswas |
| Designation |
Professor and HOD |
| Affiliation |
The Calcutta Homoeopathic Medical College and hospital |
| Address |
The Calcutta Homoepathic Medical College and Hospital.
265 266 APC Road. Kolkata
Department of Gynae,room no 06
Kolkata
WEST BENGAL
700009
India |
| Phone |
8910487012 |
| Fax |
|
| Email |
drdebashisb4u@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debashis Biswas |
| Designation |
Professor and HOD |
| Affiliation |
The Calcutta Homoeopathic Medical College and hospital |
| Address |
The Calcutta Homoepathic Medical College and Hospital.
265 266 APC Road.
Kolkata
WEST BENGAL
700009
India |
| Phone |
8910487012 |
| Fax |
|
| Email |
drdebashisb4u@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debashis Biswas |
| Designation |
Professor and HOD |
| Affiliation |
The Calcutta Homoeopathic Medical College and hospital |
| Address |
The Calcutta Homoepathic Medical College and Hospital.
265 266 APC Road.
Kolkata. department of Gynae, Room no 06.
WEST BENGAL
700009
India |
| Phone |
8910487012 |
| Fax |
|
| Email |
drdebashisb4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College and Hospital. 265-266 APC Road.Kolkata-700009 |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
The Calcutta Homoeopathic Medical College and Hospital 265 266 APC Road. Kolkata-700009
Department of Gynae, room no 06.
Kolkata-700009 |
| 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 Debashis Biswas |
The Calcutta Homoeopathic Medical College and Hospital |
The Calcutta Homoeopathic Medical College and Hospital,265 266 APC Road.
Gynae Department,room no 06.
Kolkata 700009
Kolkata
WEST BENGAL |
8910487012
drdebashisb4u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| government of West Bengal The Calcutta Homoepathic Medical College and Hospital (State Model Homoeopathic Institution) 265 266 APC Road,Institutional Ethical Committeel Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 placebo with concomitant care. |
This group will receive placebo, 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 in 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. Duration of therapy: 3months. Both medicines and placebos will be re-packed in
identical glass bottles and labelled with code, name of medicines, potency, and will be
dispensed according to the random number list. |
| Intervention |
Individualised homoeopathic medicine in appropriate potencies based on the presenting totality of symptoms. |
i. Intervention: Patients will be given Individualised homoeopathic medicine in appropriate potencies based on the presenting totality of symptoms.
ii. Procurement of medicine: Homoeopathic medicine to be used in the study will be dispensed from the already available storage of medicine in the pharmacy of the institution. All these medicines were procured from dispensing unit of CHMCH.
iii. Selection of medicine: Patients will be given homoeopathic medicine, selected on the basis of totality of symptoms. Thus, the study will be based on the basic principle of individualization in homoeopathy
iv. Selection of potency: The treatment for each patient will always begin with lower (6cH/12cH/30cH) potencies and to be followed subsequently by next higher potencies as per need of the case.
v. Dose: Each dose, to be taken orally on clean tongue, will consist of 4 cane sugar globules of size 30, moistened with a single drop of indicated medicine prepared with 88% v/v dispensing alcohol.
vi. Repetition of medicine: Repetition will be done depending on the intensity of the complaints. Patient will be followed up after each 30 days. Data will be collected on the above-mentioned days of visits.
duration of treatment for each patients will be 3 months.
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
i. Inclusion criteria:
a. 13-30 years Youth females (adolescents and adult female)
b. Having moderate or severe primary dysmenorrhea in the recent cycles
c. Normal menstrual cycle for more than 6 months
d. Have experienced two or more symptoms associated with primary dysmenorrhoea: (nausea, vomiting, diarrhoea, constipation, fatigue, irritability, breast tenderness).
e. Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires.
f. Literate participant able to read and write in English, Hindi or Bengali
g. Participants providing with written informed consent.
|
|
| ExclusionCriteria |
| Details |
a. Being under age of 13yrs and above the age of 30yrs.
b. Suffering from a diagnosed gynaecological illness.
c. Having undergone childbirth.
d. Using oral contraceptive pills or corticosteroids or having a history of their use in previous 6 months.
e. Pregnant or lactating women
f. Unstable mental or psychiatric illness or other systemic diseases (e.g., uncontrolled hypertension, diabetes, thyroid diseases etc.) affecting quality of life or any vital organ failure.
g. Any substance abuses
h. Self-reported immune – compromised state
i. Patients who are too sick for consultation
j. Simultaneous participation of any other clinical trials
k. Undergoing homoeopathic treatment for any chronic disease within last 6 month
|
|
|
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 |
| Parameters for outcome assessment is the 0-10 Numeric Rating Scale score (NRS) |
2 years or till sample size achieved. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dysmenorrhea Symptom Interference Scale (DSI) questionnaire. |
2 years or till sample size achieved. |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
15/06/2024 |
| 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="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
|
Primary dysmenorrhea comes under synonyms of dysmenorrhea under GA34.3 of ICD-11. Its onset occurs mainly during adolescence, within 6 to 24 months after menarche. Dysmenorrhea pain has a clear and cyclic pattern, which is typically severe during the first day of menses and lasts up to 72 hours. Secondary dysmenorrhea refers to pain in the presence of pelvic disease. In addition to lower abdominal/pelvic pain, dysmenorrhea is usually associated with common symptoms, that can be categorized into two main dimensions: physical and psychological symptoms. The commonly experienced physical symptoms are systemic, gastrointestinal, and elimination-related. There is quite lack of data available in homoeopathy in treatment of primary dysmenorrhoea. keeping in view this lack of validated clinical trial on hemorrhoid, we aimed to evaluate effects of homoeopathic medicines beyond placebo by conducting this double- blind, placebo controlled trial of individualised homoeopathic medicines against placebo at The Calcutta Homoeopathic Medical College & Hospital on 68 participants with primary dysmenorrhoea. Parameters for outcome assessment in English, Bengali and Hindi version of the NRS and DSI questionnaire. It is a reliable, valid, and sensitive instruments for measurement of pain and overall well-being patients suffering from Primary Dysmenorrhoea.. |