| CTRI Number |
CTRI/2024/05/067621 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pain in shoulder and restricted movements in patients of aged above 40yrs are treated with homoeopathic medicines and results are compared before and after 3 months. |
|
Scientific Title of Study
|
EFFECT OF INDIVIDUALISED HOMOEOPATHIC TREATMENT IN 50 MILLESIMAL SCALE ON FUNCTIONAL OUTCOME OF ADHESIVE CAPSULITIS-AN OPEN LABEL PROSPECTIVE 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 |
Dr Savitha Sharma |
| Designation |
Post-graduate trainee |
| Affiliation |
National institute of Homoeopthy |
| Address |
OPD no 14-Department of organon of medicine. National institute of Homoeopathy. GE block, Sector-3, Salt lake, Kolkata, West Bengal 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
7337782376 |
| Fax |
|
| Email |
savithasharmanih@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr INDRANI CHAKRABARTI |
| Designation |
Associate Professor |
| Affiliation |
National institute of Homoeopthy |
| Address |
National institute of Homoeopathy. GE block, Sector-3, Salt lake, Kolkata, West Bengal-700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
09433902555 |
| Fax |
|
| Email |
indraniabc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr INDRANI CHAKRABARTI |
| Designation |
Associate Professor |
| Affiliation |
National institute of Homoeopthy |
| Address |
National institute of Homoeopathy. GE block, Sector 3, Salt lake , Kolkata, West Bengal 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
09433902555 |
| Fax |
|
| Email |
indraniabc@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of Homoeopathy, GEBlock, Sector 3, Salt lake, Kolkata, West Bengal 700106 |
|
|
Primary Sponsor
|
| Name |
National institute of Homoeopathy |
| Address |
National institute of homoeopathy, GE block, sector 3, salt lake, kolkata, westbengal, 700106 |
| 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 Indrani Chakrabarti |
National institute of Homoeopathy |
OPD no 14- department of organon of medicine. National institute of homoeopathy. GE block sector 3, salt lake , kolkata, west bengal 700106
North Twentyfour Parganas
WEST BENGAL |
09433902555
indraniabc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of National institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individulised Homoeopthic mediine in 50 Millesimal Potency in suitable dosage. |
All Patients will be prescribed individualised Homoeopathic medicine in 50 millesmal potency. After detailed case taking in accordance with the directions given by Dr.C.F.S Hahnemann in Organon of medicine in 6th edition. The follow up will be done monthly till 3 months from the baseline. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with clinically diagnosed case of Adesive capsulitis who are willing to give consent for study. |
|
| ExclusionCriteria |
| Details |
1. Cases suffering from uncontrolled systemic illness or life threatening disease.
2. Pregnant women and lactating Mothers.
3. Patient who are taking Other mode of Treatment for the same.
4. Simultaneous participation in any other clinical trial.
5. Patient under substance abuse or dependence.
6. Diagnosed cases of unstable mental or psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ASES SCORE (Assessing pain in shoulder)) |
baseline and 3 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ASES score ( Assesing Quality of life activities ) |
baseline and at 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/06/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Adhesive Capsulitis of Shoulder characterised by pain and majorly affecting the movements of the joint nearly complete loss of passive and active external rotation of the shoulder. Commonly seen in manual workers with prevalance rate of 2-5% in general population. In prospective study of 41 patients with 5 to 10 years followup found only 39% of patients had full recovery. Only few studies had been happened in the past on the effectiveness of Homoeopathic medicine in Adhesive Capsulitis and no study was done under 50 millesimal scale of Homoeopathic medicines in treating adhesive capsulitis. In Adhesive capsulitis severe pain and restricted movements are present for long terrm, so Its necessary to observe the effectiveness of 50Millesimal scale on this condition. As in this scale medicines can be repeated regularly with no Aggravations. Thus the study has been taken to see whether there is significant change in ASES score for Adhesive cpasulitis using individualised homoeopathic medicine in 50 millesimal scale. The study will be carried out at National institute of Homoeopathy. The sources of the samples will be the patients attending out patient department and Indoor patient department of the hospital. One year study with 3 months followup of each and every case with sample size of 40 patients are considered for a study of Non randomised, open label, single arm, prospective clinical study. Proper case taking of all enrolled patients will be done as per protocol and guidelines in the Organon of medicine 5th and 6th edition. Individualised Homoeopathic medicines will be prescibed in 50 millesimal potency in suitable doses. Each case will be assessed montly to followup the remedy reaction and ASES score quessionaire will be taken from Patients at the base line and after 3 months of treatment. ASES score is 100 point scale that evaluates 2 dimesnions of shoulder function that is both Pain and Performance of activities of daily living.The score obtained by patients will be compared and result analysed as per appropriate statistical methods and inference will be done thereafter. Theresult will be publised in scientific journals. |