| CTRI Number |
CTRI/2025/07/091934 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing homoeopathic intervention alone versus homoeopathy intervention with auxiliary measures in improving chronic joint pain in adults aged 18 to 65 years |
|
Scientific Title of Study
|
Comparative study to evaluate the synergistic impact of
Homoeopathic treatment combined with manual therapeutics self massage MTSM
versus Homoeopathic treatment alone in treating chronic joint pain using brief pain
inventory |
| 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 Nidhi Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Homoeopathy University |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy Room No 2 Unit 1 Constituent hospital of Homoeopathy University Plot No 10 11 12 Saipura Sanganer Jaipur 302029
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302029
India |
| Phone |
8949211948 |
| Fax |
|
| Email |
dr.nidhi12homoeopathy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Homoeopathy University |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy Room No 2 Unit 1 Constituent hospital of Homoeopathy University Plot No 10 11 12 Saipura Sanganer Jaipur 302029
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302029
India |
| Phone |
8949211948 |
| Fax |
|
| Email |
dr.nidhi12homoeopathy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Homoeopathy University |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy Room No 2 Unit 1 Constituent hospital of Homoeopathy University Plot No 10 11 12 Saipura Sanganer Jaipur 302029
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302029
India |
| Phone |
8949211948 |
| Fax |
|
| Email |
dr.nidhi12homoeopathy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Girendra Pal Homoeopathic Hospital and Research Centre |
| Address |
Homoeopathy University Plot No 10 11 12 Saipura Sanganer Jaipur 302029 |
| Type of Sponsor |
Other [Homoeopathy University] |
|
|
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 Nidhi Sharma |
Dr Girendra Pal Homoeopathic Hospital and Research Centre Jaipur |
Department of Organon of Medicine and Homoeopathic Philosophy Room No 2 Unit 1 Constituent hospital of Homoeopathy University Plot No 10 11 12 Saipura Sanganer Jaipur 302029
Jaipur
RAJASTHAN |
8949211948
dr.nidhi12homoeopathy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Homoeopathy University Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Homoeopathic Treatment |
Homoeopathic treatment
alone in treating chronic joint pain |
| Intervention |
Homoeopathic treatment combined with integrative auxiliary measures |
Homeopathic treatment
with Manual Therapeutic Self-Massage (MTSM) as an auxiliary measure for chronic joint pain |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults aged 18-65 years with a diagnosis of chronic joint pain lasting at least three months.
2.Pain severity between 4 and 8 on the Brief Pain
Inventory (BPI) scale, indicating moderate to severe pain.
3.No significant systemic diseases or joint pathologies beyond chronic pain
4.Ability to understand and complete the BPI questionnaire, ensuring valid and reliable self
reports.
5.Providing consent to adhere to both homeopathic
treatment and self-massage protocols, including
regular follow-ups. |
|
| ExclusionCriteria |
| Details |
1.Recent surgery or acute injury affecting the joints within the last six months
2.Contraindications to massage therapy, such as severe cardiovascular conditions or skin infections.
3.Concurrent use of experimental or other non standard pain treatments that could confound results.
4.Cognitive impairments or psychiatric conditions that impair the ability to complete questionnaires or follow treatment protocols.
5.Pregnancy or breastfeeding, due to potential
contraindications with the treatment or additional
risks. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in chronic joint pain measured by the Brief Pain Inventory BPI total score |
BPI score measured at baseline, at end of 3 months and at end of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain severity reduction assessed through BPI
sub-scores for example worst least average and current
pain levels |
Measured at baseline, at end of 3 months and at end of 6 months |
| Pain interference improvement changes in BPI sub-scores related to the impact of pain on daily activities for example work sleep and mood |
Measured at baseline, at end of 3 months and at end of 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="3"
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
|
Null Hypothesis There is no significant difference in
the effectiveness of homoeopathic treatment combined with integrative auxiliary
measures and homoeopathic treatment alone in reducing chronic joint pain as
measured by the Brief Pain Inventory
Alternative
Hypothesis There is a significant
difference in the effectiveness of homoeopathic treatment combined with
integrative auxiliary measures compared to homoeopathic treatment alone in
reducing chronic joint pain as measured by the Brief Pain Inventory
Objectives To compare the effectiveness of homeopathic
treatment with and without Manual Therapeutic Self Massage MTSM as an auxiliary
measure for chronic joint pain the Brief Pain Inventory BPI questionnaire will
be utilized to assess pain levels and functional improvements.
Intervention Dose of well selected remedy shall be governed
by individualistic approach in each case of both the groups Additionally one group will receive a Manual
Therapeutic Self Massage Plan designed by a physiotherapist within the hospital
setting Medicines shall be administered
via oral route most preferably Dispensing of the medicine shall be done by
Hospital Pharmacist
Follow-Up measured at baseline at the end of 3 months and at the end of 6
months on the basis of BPI score |