| CTRI Number |
CTRI/2022/09/045691 [Registered on: 20/09/2022] Trial Registered Prospectively |
| Last Modified On: |
16/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Upanaha(poultice)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate efficacy of Godhumadi upanaha in frozen shoulder |
|
Scientific Title of Study
|
“A Randomized, Controlled, Clinical Study To Evaluate Efficacy Of Godhumadi
Upanaha In Avabahuka With Special Reference To Frozen Shoulderâ€
|
| Trial Acronym |
GUAFl |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aniruddha Prakash Ponkshe |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
Room no. 18, Department of kayachikitsa , Government Ayurved College, Nanded
Nanded
MAHARASHTRA
431602
India |
| Phone |
9082905721 |
| Fax |
|
| Email |
apponkshe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pathan SI |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
Room no. 18, Department of kayachikitsa, Government Ayurved College, Nanded
Nanded
MAHARASHTRA
431602
India |
| Phone |
9665311877 |
| Fax |
|
| Email |
shamshirkhan680@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pathan SI |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
Room no. 18, Department of kayachikitsa, Government Ayurved College, Nanded
Nanded
MAHARASHTRA
431602
India |
| Phone |
9665311877 |
| Fax |
|
| Email |
shamshirkhan680@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self sponsored, OPD and IPD of Kayachikitsa department, Government Ayurved College, Nanded |
|
|
Primary Sponsor
|
| Name |
Aniruddha Ponkshe |
| Address |
Room no.18 Kayachikitsa Department
Government Ayurved College
Nanded |
| Type of Sponsor |
Other [Self sponsered] |
|
|
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 |
| Aniruudha Prakash Ponkshe |
OPD kayachikitsa department |
Government Ayured Hospital Nanded
Nanded
MAHARASHTRA |
9082905721
apponkshe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M750||Adhesive capsulitis of shoulder. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Atasi Upanaha | (Procedure Reference: Charaka Sutrasthana, Procedure details: Upanaha made with the help of Tila Taila,Saindhava, Jambeer Swarasa,Atasi churna and water. This is appied over shoulder joint for 12 hours overnight with the help of cotton bandage. Same procedure for 7 days. )
| | 2 | Intervention Arm | Procedure | - | Godhumadi Upanaha | (Procedure Reference: Charaka Sutrasthana, Procedure details: Upanaha made with the help of Tila Taila,Saindhava, Jambeer Swarasa, Yava and Godhum churna and water. This is appied over shoulder joint for 12 hours overnight with the help of cotton bandage. Same procedure for 7 days. )
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed as frozen shoulder
Patient irrespective of caste,religion
Ipd and opd patients of the hospital,in the institution
All patients having pain and restricted movements of shoulder joint in presence of normal radiograph
|
|
| ExclusionCriteria |
| Details |
Pregnant woman
Those having fracture or dislocation of shoulder joint
Patient with major systemic disorder like hepatic, renal or polyarthritis, rheumayoid arthritis etc
Those who need other emergency interventions like surgery
Patient with uncontrolled diabetes mellitus
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To reduce pain in frozen shoulder
To increase range of motion in frozen shoulder
To increase grades of mobility |
0th day, 4th day, 8th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Godhumadi Upanaha is better than Atasi Upanaha in management of Frozen Shoulder |
In 7 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
22/09/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is Randomised , Controlled, Clinical study of Godhumadi Upanaha applied 12 hours overnight for 7 days, and follow up on 4th and 8th day. This study os conducted as PG course at single center. The primary outcome is to study the efficacy of Godhumadi Upanaha in the management of Avabahuka with special reference to Frozen Shoulder. |