| CTRI Number |
CTRI/2023/09/057455 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
08/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study of varunadi churna pinda swedan procedure for pain and stiffness of shoulder |
|
Scientific Title of Study
|
Randomized controlled clinical trial of varunadi churna
Pinda sweda in avabahuka with special reference to frozen shoulder |
| 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 Amruta Maruti Phadake |
| Designation |
Post Graduate Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 09 Panchakarma OPD ground floor Dhanvantari Ayurved hospital Ashta Tal WalWa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8788698546 |
| Fax |
|
| Email |
amrutamarutiphadake@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Wadkar |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
4th floor Department of Panchakarma Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal WalWa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8888817891 |
| Fax |
|
| Email |
archanaswadkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Wadkar |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
4th floor Department of Panchakarma Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal WalWa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8888817891 |
| Fax |
|
| Email |
archanaswadkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Amruta Maruti Phadake |
| Address |
OPD no 09 Panchakarma OPD ground floor Dhanvantari Ayurved hospital Ashta Tal WalWa Dist Sangli |
| Type of Sponsor |
Other [Self] |
|
|
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 Amruta Maruti Phadake |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
OPD no 09 Panchakarma OPD ground floor Dhanvantari Ayurved hospital Ashta Tal WalWa Dist Sangli
Sangli
MAHARASHTRA |
8788698546
amrutamarutiphadake@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta institutional Ethics 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 | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: Charaka samhita, Procedure details: 1 PurvakarmaÂ
i Counselling and consent for KarmaÂ
ii Sambhar SangrahaÂ
iii Preparation of nirgundi patra pinda
iv Sthank Snehan with Tila Taila
2 Pradhankarma
i The prepared nirgundi patra pinda will be heated with Warm Tila Taila
ii nirgundi patra pinda will apply on shoulder with mild pressure for 30 minutes
3 Paschat karma
i Patient Wipe off the oil from the body with clean and dry towel
ii Advise to patient to have hot water bath after 30 minutes
iii Pathya Apathya)
(1) Medicine Name: Nirgundi patra pinda, Reference: Charaka samhita, Route: Topical, Dosage Form: Not Applicable, Dose: 200(g), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: Charaka samhita, Procedure details: 1 Purvakarma
i Counselling and consent for Karma
ii Sambhar Sangraha
iii Preparation of Varunadi churna pinda
iv Sthank Snehan with Tila Taila
2 Pradhankarma
i The prepared varunadi churna pinda will be heated with Warm Tila Taila
ii Varunadi churna pinda will apply on shoulder with mild pressure for 30 minutes
3 Paschat karma
i Patient Wipe off the oil from the body with clean and dry towel
ii Advise to patient to have hot water bath after 30 minutes
iii Pathya Apathya)
(1) Medicine Name: Varunadi churna pinda, Reference: Gadanigraha, Route: Topical, Dosage Form: Churna/ Powder, Dose: 200(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient presenting with symptoms Avabahuka
2 Patients suffering from Avabahuka
3 Patient indicated for Swedana |
|
| ExclusionCriteria |
| Details |
1 Lactating mothers
2 Pregnant women
3 Dislocation of shoulder joint
4 Fracture of shoulder joint
5 Patient with infective disease
6 Patient suffering from any metabolic disorders such as SLE Rheumatoid Arthritis
7 Patient contraindicated for Swedana Karma |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of varunadi churna pinda sweda in the management of avabahuka |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To evaluate the efficacy of varunadi churna pinda sweda on signs & symptoms of avabahuka
2 To compare the effect of varunadi churna pinda sweda &
nirgundi patra pinda sweda in Avabahuka |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/09/2023 |
| 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="6"
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
|
As we see the number of patients with Avabahuka are increased now a days so this study will help to the patients for reduce pain and stiffness of shoulder. This study is randomized controlled clinical trial of varunadi churna pinda sweda in Avabahuka with special reference to Frozen shoulder as trial drug and nirgundi patra pinda sweda as control drug. Trial and control drugs applied in the form of pinda sweda on the diagnosed cases of Avabahuka for 7 days. After 7 days patient is advice to come on 14th day for follow up. 35 patients in each group will be studied. Study will be conducted in India. Outcome of study will be asses on reduction of signs and symptoms of Avabahuka |