| CTRI Number |
CTRI/2025/09/094494 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathy in the treatment of Fibromyalgia using Synthetic Repertory |
|
Scientific Title of Study
|
Effect of Individualized Homoeopathic medicines using the Synthetic Repertory in the management of Fibromyalgia a prospective single arm study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ibtisam Naz |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no B 15
Department of Homoeopathic Repertory and Case Taking
Floor basement
36 B Knowledge park phase 1 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
7003302917 |
| Fax |
|
| Email |
nazibtisam786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailja Upadhyay |
| Designation |
Associate professor |
| Affiliation |
Bakson homoeopathic medical college and hospital |
| Address |
Room no B 15
Department of homoeopathic repertory and case taking
Floor basement
36 B Knowledge park phase 1 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8447753501 |
| Fax |
|
| Email |
drshailjaupadhyay22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Goyal |
| Designation |
Professor HOD |
| Affiliation |
Bakson homoeopathic medical college and hospital |
| Address |
Room no B 15
Department of homoeopathic repertory and case taking
Floor basement
36 B Knowledge park phase 1 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9910797598 |
| Fax |
|
| Email |
draditigoyal19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital
Room no G 22
Principal office
Ground floor
36 B knowledge park phase 1 Greater Noida Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no G 22
Principal office
Ground floor
36 B Knowledge park phase 1 Greater Noida Uttar Pradesh |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ibtisam Naz |
Bakson Homoeopathic Medical College and Hospital |
Out patient department
Room no 1
Ground floor
Plot no 36 B Knowledge park phase 1 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
7003302917
nazibtisam786@gmail.com |
| Dr Ibtisam Naz |
Dr D P Rastogi Central Research Institute of Homoeopathy |
General opd
Room no 110
Ground floor
A 1/1
opposite hcl
sector 24 noida
Gautam Buddha Nagar
UTTAR PRADESH |
7003302917
nazibtisam786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson Homoeopathic Medical College |
Approved |
| Kendriya Homoeopathic Anusandhan Parishad |
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 |
Homoeopathic medicines |
Pill form of administration
Route of administration - Oral
30 pill size
Centesimal scale
First dose after case taking
Repetition of dose - every 4 weeks
Total duration - 6 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18 to 59 years irrespective of their sex socioeconomic status and occupation
Participants diagnosed with fibromyalgia according to the american college of rheumatology 2016 criteria
Participants who have willingly joined the study and signed the written informed consent form
Participants currently taking medications from other systems of medicine will be enrolled only after completing a two-week washout period provided they are willing to discontinue such medicines
The occasional use of mild painkillers example paracetamol will be permitted
The number and frequency of painkiller doses will be carefully documented at baseline and monitored throughout the study for comparison before and after treatment
|
|
| ExclusionCriteria |
| Details |
Participants diagnosed with other chronic pain syndromes
Participants diagnosed with hypothyroidism
Participants with severe alcohol dependence
Presence of severe psychiatric illness
Pregnant or lactating women
Participants diagnosed with other immunocompromised conditions and autoimmune diseases
Participant on medications that cannot be safely stopped or tapered without the authorized physician supervision or where such supervision is unavailable.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in pain fatigue levels and sleep quality using Revised Fibromyalgia Impact Questionnaire before and after giving individualized Homoeopathic medicines |
16 months study
6 months enrolment
6 months follow up
2 months data analysis
2 months report writing
Revised fibromyalgia impact questionnaire is used
statistical data analysis done at baseline 3rd month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the change in stress levels among participants receiving individualized Homoeopathic treatment using the Perceived Stress Scale |
16 months study
6 months enrolment
6 months follow up
2 months data analysis
2 months report writing
Revised fibromyalgia impact questionnaire is used
statistical data analysis done at baseline 3rd month and 6th month |
| To evaluate the changes in quality of life in fibromyalgia participants following individualized homoeopathic management, measured by the EQ 5D 5L EuroQol 5 Dimension 5 Level questionnaire. |
16 months study
6 months enrolment
6 months follow up
2 months data analysis
2 months report writing
Revised fibromyalgia impact questionnaire is used
statistical data analysis done at baseline 3rd month and 6th month |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
22/09/2025 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Role of individualized Homoeopathic medicines in 35 participants with fibromyalgia using Synthetic Repertory. Revised Fibromyalgia Impact Questionnaire, Perceived Stress Scale and EQ 5D 5L Questionnaire is used for data analysis. Data will be analyzed by using one way repeated ANOVA test. Assessment of data will be done at baseline at 3rd month and at 6th month.
|