| CTRI Number |
CTRI/2025/12/099597 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
21/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness Of Individualised Homoeopathic Medicine In Females With Fibromyalgia |
|
Scientific Title of Study
|
A Prospective Interventional Study: Effectiveness Of Individualised Homoeopathic Medicine In Females Of 30-60 Years Of Age With Fibromyalgia Assessed By Fibromyalgia Impact Questionnaire-Revised (FIQ-R) |
| 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 Jammalamadugu Damini |
| Designation |
Pg Scholar |
| Affiliation |
JIMS Homoeopathic Medical College and Hospital |
| Address |
JIMS Homoeopathic Medical College and Hospital
Sriramnagar Muchintal
Hyderabad
Telengana
509325
India OPD 6 Department Of Practice Of Medicine JIMS Homoeopathic Medical College and Hospital
Sriramnagar Muchintal
Hyderabad
Telengana
509325
India Hyderabad TELANGANA 509325 India |
| Phone |
9391493825 |
| Fax |
|
| Email |
jdaminisudarshan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vibhavya S |
| Designation |
Professor |
| Affiliation |
JIMS Homoeopathic Medical College and Hospital |
| Address |
OPD 6 Department Of Practice Of Medicine JIMS Homoeopathic Medical College and Hospital
Hyderabad
Telengana
509325
India OPD 6 Depatment Of Practice Of Medicine JIMS Homoeopathic Medical College and Hospital
Hyderabad
Telengana
509325
India Hyderabad TELANGANA 509325 India |
| Phone |
9391493825 |
| Fax |
|
| Email |
vibhavya.shetty@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jammalamadugu Damini |
| Designation |
Pg Scholar |
| Affiliation |
JIMS Homoeopathic Medical College and Hospital |
| Address |
OPD 6 Depatment Of Practice Of Medicine JIMS Homoeopathic Medical College and Hospital
Hyderabad
Telengana
509325
India OPD 6 Depatment Of Practice Of Medicine JIMS Homoeopathic Medical College and Hospital
Hyderabad
Telengana
509325
India Hyderabad TELANGANA 509325 India |
| Phone |
9391493825 |
| Fax |
|
| Email |
jdaminisudarshan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIMS Homoeopathic Medical College and Hospital |
| Address |
JIMS Homoeopathic Medical College and Hospital Sriramnagar Muchintal Hyderabad Telangana 509325 |
| Type of Sponsor |
Private 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 Jammalamadugu Damini |
JIMS Homoeopathic Medical College and Hospital |
OPD 6 Department Of Practice Of Medicine JIMS Homoeopathic Medical College and Hospital
Sriramnagar Muchintal Hyderabad
Telangana Hyderabad TELANGANA |
9391493825
jdaminisudarshan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECJIMS |
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 |
Individualised Homoeopathic Medicine |
Medicines Will Be Prescribed Based On The Selected Similimum From The Repertory With Each Dose Consisting
Of 4 Pills Of Size No 20 Potency Selection And Repetition Of Doses Will Be Determined According To The Patients
Susceptibility With Treatment Duration Typically Spanning 4 Weeks Involving Initial Daily or Biweekly Doses
Followed By Spacing Based On Response Until Symptom Resolution |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Fulfilling ACR 2016 Criteria For Fibromyalgia |
|
| ExclusionCriteria |
| Details |
Moderate And Severe Depressive Disorder Patients Assessed By Psychiatrist Using The Hamilton Depression Rating Scale
Current Use Of Corticosteroids Or Immunosuppressants
Other Autoimmune Disorders
Pregnant Women and Lactating Mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess The Change In FIQ-R (Fibromyalgia Impact Questionnaire – Revised) Scores After Administration Of Individualized Homoeopathic Medicine Over a Period of 6 Months In Females Aged 30-60 Years Diagnosed With Fibromyalgia |
To Assess The Change In FIQ-R (Fibromyalgia Impact Questionnaire – Revised) Scores After Administration Of Individualized Homoeopathic Medicine Over a Period of 6 Months At Baseline And At 6 Month In Females Aged 30-60 Years Diagnosed With Fibromyalgia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
16/01/2026 |
| 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="2" 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
|
Fibromyalgia is a chronic, multi-system pain disorder characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and impaired quality of life. Conventional treatment often provides incomplete relief, highlighting the need for integrative and individualized therapeutic approaches. This prospective interventional study aims to evaluate the effectiveness of individualized Homoeopathic medicine in females aged 30–60 years diagnosed with fibromyalgia, using the Revised Fibromyalgia Impact Questionnaire (FIQ-R) as the primary outcome measure. Eligible participants will be recruited based on ACR diagnostic criteria and assessed for miasmatic background and totality of symptoms. Individualized prescriptions will be administered according to Hahnemannian principles, with follow-ups at defined intervals over a 16-week period. Pre- and post-intervention scores of FIQ-R, along with secondary parameters such as sleep quality, tenderness, and functional capacity, will be statistically analyzed. The study seeks to determine whether individualized Homoeopathic treatment produces significant improvement in symptom severity and quality of life. Findings may contribute evidence toward the role of Homoeopathy as a supportive and individualized modality in fibromyalgia management. |