| CTRI Number |
CTRI/2024/12/077618 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| 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 treatment of muscle pain |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in the treatment of fibromyalgia in adults: A double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1316-1165 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhadra Saha |
| Designation |
Postgraduate Trainee |
| Affiliation |
D.N.De Homoeopathic Medical College |
| Address |
Dept. of Practice of Medicine, OPD room no. PG5 (Medicine) and 1 (Medicine), 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
|
| Fax |
|
| Email |
ria38045@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Veena Prakash Bharti |
| Designation |
Reader |
| Affiliation |
D.N.De Homoeopathic Medical College |
| Address |
Dept. of Practice of Medicine, OPD room no. PG5 (Medicine) and 1 (Medicine), 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9231692840 |
| Fax |
|
| Email |
drvpbharti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Veena Prakash Bharti |
| Designation |
Reader |
| Affiliation |
D.N.De Homoeopathic Medical College |
| Address |
Dept. of Practice of Medicine, OPD room no. PG5 (Medicine) and 1 (Medicine), 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9231692840 |
| Fax |
|
| Email |
drvpbharti@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 |
| 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 Subhadra Saha |
D.N.De Homoeopathic Medical college and hospital |
Dept of practice of medicine , OPD PG5 and medicine , kolkata 700046
Kolkata
WEST BENGAL |
8910017901
ria38045@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: M797||Fibromyalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical looking placebo plus concomitant care |
This arm will be given a placebo that looks exactly like verum.
Each dose of the placebo will consist of four (number forty) cane sugar globules,
moistened with rectified spirit, to be taken orally on an empty stomach and clean
tongue; the dosage and repetition depend on the specific needs of each patient management guidelines will be given as in the experimental arm.The therapy lasted for three months. The medications and placebos will be repackaged in
matching glass bottles, labeled with the medications name, potency, and code. The
random number list will be used to determine how the medications are given.concomitant care measures include gentle physical aerobic and strength training exercises .Route of Administration : per oral. Duration of follow up:3 months. |
| Intervention |
Individualized homoeopathic medicines in individualized dosage in centesimal potencies plus concomitant care |
The proposed intervention entails the administration of
prescribed homoeopathic medications at centesimal potencies (CH). Every
dosage consists of four No. 40 cane sugar globules moistened with the prescribed medication (kept in 90% v/v ethanol), which is to be taken orally
on an empty stomach with a clean tongue. The dosage and frequency of administration depend on the specific needs of each case. Patients will be
instructed to suck the globules rather than swallow them, and they will be
forbidden from handling the globules or from eating, drinking, smoking, or
brushing their teeth for 30 minutes after ingesting them. Every time, a single,
customized medication will be recommended, taking into consideration the
entirety of the patients presenting symptoms, the clinical history, the patients constitutional characteristics, any miasmatic expressions, and when
necessary, repertorization utilizing ZOMEO software. concomitant care measures include gentle physical aerobic and strength training exercises .Route of Administration : per oral. Duration of follow up:3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who have received a diagnosis of primary fibromyalgia according to The American College of Rheumatology 2010 criteria for the classification of fibromyalgia
â–ª Widespread pain score 7 or more
â–ª Based on severity of symptom (SS 5 or more)
2. Age between 18 and 65 years
3. Symptoms are present for at least 3 months.
4. Participants of either sex or transgender.
5. Patients ability to understand English / Hindi / Bengali |
|
| ExclusionCriteria |
| Details |
1.Not providing with written informed consent of participation.
2. Participants despite meeting the ACR 2010 fibromyalgia criteria , having PDS / FM Scale (WPI+SS), None (0-3) , Mild (4–7) , Moderate (8-11), Very severe (20–31)
3. A current diagnosis of infection or Musculoskeletal inflammatory conditions
4. Non-ambulant patients.
5. Self-reported conditions other than fibromyalgia.
6. Patients who are too sick for consultation.
7. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled
systemic or life-threatening illness affecting quality of life or any organ failure.
8. Pregnancy, puerperal women and lactating mother.
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
11. Undergoing homoeopathic treatment for any chronic disease within last 3 months.
12. Simultaneous participation in any other clinical trial |
|
|
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 |
| The Revised Fibromyalgia Impact Questionnaire (FIQR) |
Baseline, and every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Multi Dimensional questionnaire for patient reported outcome measures - Fibromyalgia (PROM FM) |
Baseline, and every month, up to 3 months |
| Measure yourself Medical Outcome Profile v-2 (MYMOP-2) questionnaire |
Baseline, and every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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
|
N/A |
|
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)
Modification(s)
|
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 [ria38045@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 12-03-2031?
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
|
Fibromyalgia is a chronic pain syndrome characterized by widespread pain, sometimes with accompanying symptoms such as persistent tiredness and disturbed sleep. Globally, fibromyalgia prevalence varies: it can be found in the general population between 0.2 and 6.6%, in women between 2.4 and 6.8%, in urban areas between 0.7 and 11.4%, and in rural areas between 0.1 and 5.2%. An Indian study found a frequency of 0.05 in this range .Traditional fibromyalgia treatments frequently involve physical therapy and painkillers. However, there’s a chance that these therapies have unintended adverse effects and don’t always offer long-term relief were noteworthy findings supporting homoeopathy, most of which showed promising outcomes, It may have enormous promise for fibromyalgia symptom relief; However, due to methodological issues and a dearth of trials, the symptomatic treatment of IHMs was poorly studied. Under such circumstances, we intend to undertake this research project to evaluate the efficacy of IHMs in the symptom management in adults. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 54 adults who are suffering from fibromyalgia at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. The primary outcome measure is FIQR Score ;the secondary outcomes are PROM-FM and MYMOP 2 questionnaires, all are measured at baseline and every month up to 3 months. Comparative analysis will be carried out to detect group differences. Result will be published in scientific journals. |