| CTRI Number |
CTRI/2025/02/080313 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study effect of mashadi taila consuming orally on shoulder joint stifness . |
|
Scientific Title of Study
|
"A Single arm clinical study to evaluate the efficacy of mashadi taila administrated orally in the management of avabahuka(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 Himani Samadhan Bankar |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr.D Y Patil college of ayurveda and research centre ,pimpri,pune |
| Address |
OPD no 5 of Dr D Y Patil college of ayurveda and reseaech centre ,Sant Tukaram nagar ,pimpri,pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
07620761912 |
| Fax |
|
| Email |
himanisbankar24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Bokade |
| Designation |
Professor (Kayachikitsa) |
| Affiliation |
Dr.D Y Patil college of ayurveda and research centre ,pimpri,pune |
| Address |
OPD no 5 of Dr D Y Patil college of ayurveda and reseaech centre ,Sant Tukaram nagar ,pimpri,pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9657222876 |
| Fax |
|
| Email |
vrushalikumbhare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Bokade |
| Designation |
Professor (Kayachikitsa) |
| Affiliation |
Dr.D Y Patil college of ayurveda and research centre ,pimpri,pune |
| Address |
OPD no 5 of Dr D Y Patil college of ayurveda and reseaech centre ,Sant Tukaram nagar ,pimpri,pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9657222876 |
| Fax |
|
| Email |
vrushalikumbhare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D Y Patil college of ayurveda and research centre ,pimpri,pune india 411081 pune |
|
|
Primary Sponsor
|
| Name |
Dr Himani Samadhan Bankar |
| Address |
Dr.D Y Patil college of ayurveda and research centre ,pimpri,pune 411081 india |
| 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 Himani Samadhan Bankar |
Dr.D Y Patil college of ayurveda and research centre ,pimpri,pune |
OPD No 5 (kayachikitsa) ground floor Dr D Y Patil college of ayurveda and research centre pimpri pune 411018
Pune
MAHARASHTRA |
07620761912
himanisbankar24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr DYPCA and RC institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M05-M14||Inflammatory polyarthropathies. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: mashadi taila, Reference: Bhavprakash, Route: Oral, Dosage Form: Taila, Dose: 6(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms of Avabahuka will be taken as a subject to study ,that is ,
1-Amsa shoola(shoulder pain )
2-Amsa stambha(shoulder stiffness)
3-Aakunchan prasarana kashtata(difficulty in flexion and extention of joint ). |
|
| ExclusionCriteria |
| Details |
1- Patient having diseases Vishvachi , Sandhigatavata ,Aamvata,Manyastambha.
2-patient with history of Fracture of the affected hand . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in restricted movement of shoulder joint |
15 days study with 2 follow up (7 day and 15 day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in sign and symptoms in avabahuka. |
15 days study with 2 follow up (7 day and 15 day) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
21/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
To study the efficacy of mashadi taila administrated orally in the management of avabahuka ( frozen shoulder ) and there are 30 patients enrolled in which mashadi taila will given 6ml orally with luke warm water twice a day in morning and evening after food for 15 days and follow up will be on 7th day and 15th day of the study . Reduction in sign and symptoms of avabahuka will noted and final conclusion will be drawn on the basis of statistical methods . |