| CTRI Number |
CTRI/2024/11/077281 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment in fibromyalgia syndrome in reproductive women |
|
Scientific Title of Study
|
EFFICACY OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN THE TREATMENT OF FIBROMYALGIA SYNDROME AMONG WOMEN OF REPRODUCTIVE AGE GROUP: 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 |
RAHITOSH GHOSH |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
MAHESH BHATTACHARYYA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Dr. B. N. Chakraborty Sarani, Doomurjala, Howrah- 711104. Department of Repertory
Haora
WEST BENGAL
711104
India |
| Phone |
8777363449 |
| Fax |
|
| Email |
rahitosh.ghosh143bhms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purnendu Ash |
| Designation |
Reader |
| Affiliation |
MAHESH BHATTACHARYYA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Dr. B. N. Chakraborty Sarani, Doomurjala, Howrah- 711104. Department of Repertory
Haora
WEST BENGAL
711104
India |
| Phone |
9051420436 |
| Fax |
|
| Email |
purnendubhms29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purnendu Ash |
| Designation |
Reader |
| Affiliation |
MAHESH BHATTACHARYYA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Dr. B. N. Chakraborty Sarani, Doomurjala, Howrah- 711104. Department of Repertory
Haora
WEST BENGAL
711104
India |
| Phone |
9051420436 |
| Fax |
|
| Email |
purnendubhms29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr. B. N. Chakraborty Sarani, Doomurjala, Howrah - 711104, West Bengal, India. |
|
|
Primary Sponsor
|
| Name |
Rahitosh Ghosh |
| Address |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, department of Repertory, Dr. B. N. Chakraborty Sarani, Doomurjala, Howrah-711104 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Rahitosh Ghosh |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Dr. B. N. Chakraborty Sarani, Doomurjala, Howrah- 711104. Department of Repertory, OPD No.-9
Haora
WEST BENGAL |
08777363449
rahitosh.ghosh143bhms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MAHESH BHATTACHARYYA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M797||Fibromyalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
individualized homoeopathic medicine |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 6-8 globules (no.20) of cane sugar, medicated 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. Duration of therapy 3 months. |
| Comparator Agent |
placebo |
This arm will receive placebo, indistinguishable in appearance from verum. Each dose of placebo shall consist of 6-8 globules (no.20) cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Duration of therapy 3 months. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Women of reproductive age provided who have set in menarche, does not set in menopause.
Age between 15 to 49 years.
Patients suffering from Fibromyalgia syndrome according to Fibromyalgia criteria 2016 revision of American College of Rheumatology.
Patients who will provide written informed consent.
Patients of all religions, all socioeconomic status.
|
|
| ExclusionCriteria |
| Details |
Patient suffering from any terminal illness, life threatening condition or taking medication for any major systemic diseases.
Chronic alcoholism and substance abuse.
Pregnant and lactating mothers.
Psychologically unstable patients or insane individuals.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of individualized homoeopathic medicines of women of reproductive age group having fibromyalgia syndrome through fibromyalgia impact questionnaire (FIQ) |
Assessment will be done at baseline and after three months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate causal attribution of Clinical outcome at end of treatment of Fibromyalgia syndrome by using Modified Naranjo Criteria (MONARCH) |
at end of treatment (three months) |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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 - NO
|
|
Brief Summary
|
This study is double blind randomized placebo controlled trial in patients of Fibromyalgia syndrome among women of reproductive age group. The primary outcome measure is to evaluate the effect of individualized homoeopathic medicines of women of reproductive age group having fibromyalgia syndrome through fibromyalgia impact questionnaire (FIQ) at baseline and 3 months interval with comparing placebo. The secondary outcome measure is to evaluate causal attribution of Clinical outcome at end of treatment of fibromyalgia syndrome by using Modified Naranjo Criteria (MONARCH). |