| CTRI Number |
CTRI/2025/04/085144 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Is Mashadi Kwath Nasya Along With Atasi Upnah Is More Effective Than Only Atasi Upna In The Management Of Avabahuka With Special Reference To Frozen Shoulder |
|
Scientific Title of Study
|
A Randomised Controlled Clinical
Study To Evaluate The Add On effect Of Mashadi kwath Nasya Along With Atasi Upnah 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 SANKET UTTAMRAO SHINDE |
| Designation |
PG scholar Kayachikitsa |
| Affiliation |
Government Ayurvedic college Vazirabad Nanded |
| Address |
Department of Kayachikitsa government Ayurvedic college Nanded Maharashtra India 431601 Nanded Maharashtra India
Nanded
MAHARASHTRA
431601
India |
| Phone |
7058354463 |
| Fax |
|
| Email |
sanketshinde6163@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh w Nalkande |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic college Vazirabad Nanded |
| Address |
Department of Kayachikitsa government Ayurvedic college Nanded Maharashtra India 431601 Nanded Maharashtra India
Nanded
MAHARASHTRA
431601
India |
| Phone |
9766069449 |
| Fax |
|
| Email |
mwnalkande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh w Nalkande |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic college Vazirabad Nanded |
| Address |
Department of Kayachikitsa government Ayurvedic college Nanded Maharashtra India 431601 Nanded Maharashtra India
Nanded
MAHARASHTRA
431601
India |
| Phone |
9766069449 |
| Fax |
|
| Email |
mwnalkande@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Government Ayurvedic college vazirabad Nanded 431601 INDIA MAHARASHTRA
|
|
|
Primary Sponsor
|
| Name |
Dr SANKET UTTAMRAO SHINDE |
| Address |
Government Ayurvedic college vazirabad Nanded 431601 INDIA MAHARASHTRA
|
| 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 SANKET UTTAMRAO SHINDE |
Government Ayurvedic college and Hospital, Nanded |
GOVERNMENT AYURVED COLLEGE NANDED
Nanded
MAHARASHTRA |
7058354463
sanketshinde6163@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUIONAL ETHICAL COMMITTEE GOVERNMENT AYURVED COLLEGE NANDED |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: atasi upnah, Reference: sushrut chikitsa 32/12, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 1(NA), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: local application procedure of atasi upnah
12hrs overnight for 7days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: mashadi kwath , Reference: sharangdhar samhita uttarkhand 8/37, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 4(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: mashadi kwath nasya 4 drops in each nostril
in evening Along with local application
procedure of atasi upnah 12hrs overnight for 7days(2) Medicine Name: atasi upnah, Reference: sushrut chikitsa 32/12, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 1(NA), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: local application
procedure of atasi upnah 12hrs overnight for 7days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as frozen shoulder (adhesive capsulitis).
Patients having pain,stiffness symptoms of Avabahuk.
patient fit for nasya karma.
Patient willing to sign written consent form for participation in the study.
All patients having restricted movements of shoulder joint in presence of normal X-
Ray(plain radiograph)
Patients with controlled diabetes mellitus |
|
| ExclusionCriteria |
| Details |
Patinets with disorders like muscular dystrophy ,arthritis,wasting of muscles which interfere
with the line of treatment with avabahuka.
Disloaction & fracture affecting the shoulder joint.
Preganant and lactating women.
Malignant and Immuno-compromised patients are also excluded.
Patients with uncontrolled diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Mashadi kwath nasya along with Atasi upnah in management of pain and range of movements of Avabahuka with special reference to Frozen Shoulder |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of mashadi kwath nasya along with atasi upnaha on range of motion of shoulder joint |
7 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
28/04/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is Prospective, Randomised, Open labelled control, Clinical study of effect of mashadi kwath nasya along with local application of atasi upnaha in avabahuk for 7 days.Mashadi kwatha nasya 4 drops in each nostril once a day in evening for 7 days along with local appliaction of atasi upnaha overnight for 7 days.Only local appliaction of atasi upnaha will be given to controlled group.This study is conducted at PG course at single centre. Primary outcome:- to evaluate the add on effect of mashadi kswatha nasya in avabahuk with special reference to frozen shoulder. Outcome of study will be assesd on following criteria- 1.Not cured- Pain without movement and no improvement in movements 2.Improved – pain with movements improved 3.Markedly improved –25 0 improvement in movements and improvement in subjective criteria 4.Cured –complete Improvement in subjective criteria and 250 improvement in movements |