| CTRI Number |
CTRI/2024/12/077985 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare HOMEOPATHIC medicine and placebo in frozen shoulder |
|
Scientific Title of Study
|
Individualized Homoeopathic Medicine in the treatment of Frozen shoulder using SPADI scale single blind randomised 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 |
Modi disha shaileshkumar |
| Designation |
Md HOMEOPATHIC SCHOLAR |
| Affiliation |
JAWAHARLAL nehru homeopathic medical college vadodara |
| Address |
110 2nd floor practice of medicine department jawaharlal nehru homeopathic medical college at post limda waghodia gujarat
Vadodara
GUJARAT
384315
India |
| Phone |
7984641416 |
| Fax |
|
| Email |
dishamodi86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Modi disha shaileshkumar |
| Designation |
Md HOMEOPATHIC SCHOLAR |
| Affiliation |
JAWAHARLAL nehru homeopathic medical college vadodara |
| Address |
110 2nd floor practice of medicine departmentjawaharlal nehru homeopathic medical college at post limda waghodia gujarat
Vadodara
GUJARAT
384315
India |
| Phone |
7984641416 |
| Fax |
|
| Email |
dishamodi86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kirtida desai |
| Designation |
Md HOMEOPATHIC and PROFESSOR IN PRACTICE OF MEDICINE |
| Affiliation |
JAWAHARLAL nehru homeopathic medical college vadodara |
| Address |
110 2nd floor practice of medicine departmentJAWAHARLAL nehru homeopathic medical college WAGHODIA vadodara
Vadodara
GUJARAT
390025
India |
| Phone |
9574424363 |
| Fax |
|
| Email |
kirtida.desai@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL nehru homeopathic medical college vadodara gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Modi disha |
| Address |
JAWAHARLAL nehru homeopathic medical college and hospital parul university vadodara gujarat 391760 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Zankhna desai |
JAWAHARLAL nehru homeopathic medical college vadodara 391760 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Modi disha |
JAWAHARLAL nehru homeopathic medical college and hospital |
DEPT. OF MEDICINE ROOM NO 110JAWAHARLAL nehru homeopathic medical college Parul University LIMDA, WAGHODIA vadodara gujarat
Vadodara
GUJARAT |
07984641416
dishamodi86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FERRUM MET, SANGUN CANA, SULPHUR,RHUS TOX, CAUSTICUM, RHODODENDRON MEDO FERRUM PHOS RUTA |
Individualized Homeopathic medicine like FERRUM MET, SANGUN CANA, SULPHUR,RHUS TOX, CAUSTICUM, RHODODENDRON MEDO FERRUM PHOS RUTA etc are prescribed to individuals
having contact dermatitis on the
basis of strict homoeopathic
principles. Administration of the
medicine will follow a sublingual
route. A suitable potency
(30/200/1M, etc.) will be
prescribed as per the necessity
of the case. Repetition of the
dose of homoeopathic medicine
will be done as per the
requirements of the case. The
dose will be administered and
evaluated until the
disappearance of the symptoms
Of Frozen shoulder |
| Comparator Agent |
Placebo |
placebo group patients will
receive identical
placebo(globules moistened
with dispensing alcohol)as an
add on to standard protocol
treatment. Dose repetition will
be a similar pattern to medicinal
group 2 times/day for 3 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient who are diagnosed with Apleys test
Age : 40-60 years old. who presented with limitation of range of movement (ROM) .
Both Gender and all socioeconomic classes.
Patient who are ready to give consent. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Patient is suffering from severe autoimmune diseases.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 homeopathic medicine are effective in frozen shoulder
2 reduce symptoms of Frozen shoulder |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the outcome in homoeopathic
medicinal group & placebo group by analyzing
the improvement in the frozen shoulder
The Help Of SPADI SCALE |
3 month |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
22/12/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 being conducted to evaluate the role of homeopathic medicines along with physiotherapy in cases of frozen shoulder on the basis of shoulder pain and disability index (SPADI).Which may help to boost further research in homeopathy for frozen shoulder and if we can provide a better alternative treatment for the same. focuses on the patient as a person, as well as his pathological condition. The homeopathic medicines are selected after a full individualizing examination and case-analysis, which includes the medical history of the patient, physical and mental constitution etc. A miasmatic tendency (predisposition/susceptibility) is also often taken into account for the treatment of chronic conditions. Placebo is the second-best remedy in Homoeopathy. The placebo effect refers to the phenomenon where a patient experiences an improvement in symptoms after receiving an inactive substance or intervention, simply due to their belief in its therapeutic effects. It highlights the complex relationship between the mind and body and underscores the importance of psychological factors in the healing process. The placebo effect is well-documented and has been observed across various medical conditions. It plays a significant role in clinical trials and can lead to improvements in subjective measures such as pain, mood, and overall well-being. In randomized controlled trails with homoeopathic medicines the value of placebo is unquestionable.
|