| CTRI Number |
CTRI/2019/05/019121 [Registered on: 14/05/2019] Trial Registered Prospectively |
| Last Modified On: |
13/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic treatment in cases of pain in shoulder |
|
Scientific Title of Study
|
Utility of individualized homoeopathic medicine in managing pain of adhesive capsulitis : A prospective open label observational clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gurudev Choubey |
| Designation |
RO(H),Scientist-2 |
| Affiliation |
Clinical Research Unit for Homoeopathy, Siliguri |
| Address |
Clinical Research Unit(Homoeopathy)
Gokhel Road, Arabindopally, Siliguri, West Bengal
Darjiling
WEST BENGAL
734006
India
Darjiling
WEST BENGAL
734006
India |
| Phone |
9475916907 |
| Fax |
|
| Email |
cruslg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gurudev Choubey |
| Designation |
RO(H),Scientist-2 |
| Affiliation |
Clinical Research Unit(Homoeopathy) |
| Address |
Clinical Research Unit(Homoeopathy)
Gokhel Road, Arabindopally, Siliguri, West Bengal
Darjiling
WEST BENGAL
734006
India
Darjiling
WEST BENGAL
734006
India |
| Phone |
9475916907 |
| Fax |
|
| Email |
cruslg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gurudev Choubey |
| Designation |
RO(H),Scientist-2 |
| Affiliation |
Clinical Research Unit(Homoeopathy) |
| Address |
Clinical Research Unit(Homoeopathy)
Gokhel Road, Arabindopally, Siliguri, West Bengal
Darjiling
WEST BENGAL
734006
India
Darjiling
WEST BENGAL
734006
India |
| Phone |
9475916907 |
| Fax |
|
| Email |
cruslg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, 61-65, Institutional Area, Opp. D Block,
Janakpuri, New Delhi - 110058 |
|
|
Primary Sponsor
|
| Name |
DG CCRH |
| Address |
Janakpuri,D Block,New Delhi |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Officer in Charge |
Gokhel Road, Arabindopally, Siliguri, West Bengal
Darjiling
WEST BENGAL
734006
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gurudev Choubey |
Clinical Research Unit for Homeopathy, Siliguri |
Research OPD
Gokhel Road, Arabindapally, Siliguri-734006
Darjiling
WEST BENGAL
734006
India
Darjiling
WEST BENGAL |
9475916907
gurudev.choubey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Clinical Research Unit for Homoeopathy, Siliguri |
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 |
Individulaised Homeopathic Medicine |
Initial dose: 4 globules,frequency: BD,route of administration: oral, duration of therapy: 2 month |
| Comparator Agent |
Nil |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of both gender
2.Patients within age of 30-70 years
3.Patients presenting with clinical symptoms of adhesive capsulitis of one or both shoulder
4.Patients in the stage of acute/freezing/painful stage and adhesive/frozen stiffening phase of adhesive capsulitis
5.Patient willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
1.Severe degeneration of shoulder joint with marked joint narrowing with recent shoulder surgery within last 6 months
2.Deformity of shoulder (>12o); evidence by imaging or other evidences and requiring surgical intervention
3.Self-reported joint disorders (e.g. inflammatory joint disease, specific arthropathy, severe axis deviations or instabilities, joint or skin infections, joint prosthesis of the upper limbs) other than adhesive capsulitis
4.Cases with other systemic diseases and with any vital organ failure and any self-reported immune-compromised states
5.Patients unwilling to give informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary endpoint
Pain VAS score at the end of 2 months treatment.
|
Primary endpoint
Pain VAS score at the end of 2 months treatment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary endpoint
• ORIDL and WHOQOL scale assessment after 2 months treatment.
|
6 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
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2019 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Adhesive
capsulitis, commonly referred to as frozen shoulder, is associated with
synovitis and capsular contracture of the shoulder joint and can be classified
as either primary or secondary. In present
scenario homoeopathic medicines could be a valid alternative treatment to provide
a significant improvement in pain and stiffness along with significant benefit
on overall well being of the patients. Unfortunately there is
insufficient evidence to make conclusion about the utility of individualised
homoeopathic medicine in management of adhesive
capsulitis. So a study is need to undertake to
explore the possible effects of individualized homoeopathic medicines in
relieving pain and stiffness, reduction in limitation, and disability in
activities of daily life in the patients suffering from adhesive capsulitis.
The
researchers at CRU Siliguri proposed to undertake an open label observational
clinical study to evaluate the utility of individualized homoeopathy in
management of pain and stiffness in patients with adhesive capsulitis |