| CTRI Number |
CTRI/2024/09/074236 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use Of Dashamooladi Pratimarsh Nasya And Agnikarma And Ashwagandhadi Churna In The Management Of Frozen Shoulder |
|
Scientific Title of Study
|
A Comparative Clinical Study On Dashamooladi Pratimarsh Nasya And Agnikarma Salaka Along With Ashwagandha Churna In The Management Of Avabahuka Wsr Frozen Shoulder |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Satyendra Kumar Chaudhary |
| Designation |
Pg Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur Rajasthan |
| Address |
PG Department of Shalya Tantra, OPD No. 1, MMM Government Ayurved College Hospital, Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8005708474 |
| Fax |
|
| Email |
satya.cool1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Hari Mohan Meena |
| Designation |
Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
PG Department of Shalya Tantra, OPD No. 1, MMM Government Ayurved College Hospital, Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9782166260 |
| Fax |
|
| Email |
dr_harimohan@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Satyendra Kumar Chaudhary |
| Designation |
Pg Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
| Address |
PG Department of Shalya Tantra, OPD No. 1, MMM Government Ayurved College Hospital, Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8005708474 |
| Fax |
|
| Email |
satya.cool1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| MMM Government Ayurved College, Ambamata Temple, Udaipur, Rajasthan, India, Pincode- 313001 |
|
|
Primary Sponsor
|
| Name |
MMM Government Ayurved College Ambamata Udaipur Rajasthan |
| Address |
MMM Government Ayurved College Ambamata Udaipur Rajasthan 313001 |
| Type of Sponsor |
Government medical college |
|
|
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 Satyendra Kumar Chaudhary |
Madan Mohan Malviya Govt. Ayurveda College Hospital |
Department Of Shalya Tantra, OPD No. 1 College Hospital, OPD No. 8, Moti Chohatta Hospital,
Udaipur
RAJASTHAN |
8005708474
satya.cool1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MMM Govt Ayurved College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M678||Other specified disorders of synovium and tendon. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: Chakradatta, Procedure details: Dashmool Pratimarsh Nasya With Agnikarmna And Ashwagandha Churna)
(1) Medicine Name: Dashmool, Reference: Chakradatta, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 28 Days | | 2 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Su. Su. 12, Procedure details: one sitting per week)
(1) Medicine Name: Ashwagandha, Reference: Bhavprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 4 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pain in shoulder joint
Stiffness in shoulder Joint
Patient suffering from Avabahuka (Frozen shouder) irrespective to demographic data
Patient willing to undergo trial
3. Age 20-60-years, of either sex
|
|
| ExclusionCriteria |
| Details |
Age below 20 year and above 60 year
Not willing to undergo trial
Pregnancy
Uncontrolled Diabetes Mellitus
HIV, HBsAg positive patients
Suffering from tubercular arthritis, Osteoarthritis, Gouty arthritis, and some other jointpatholog |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Asasesment Of Freezing
Assesment Of Frozen Symptom
Assesment Of Thawing
Assesment Of Restricted Active |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assesment Of Restircted Active Range Of Motion |
28 Days |
|
|
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
Modification(s)
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/10/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a comparartive clinical study On Dashamooladi Pratimarsh Nasya And Agnikarma Salaka Along With Ashwagandha Churna In The Management Of Avabhauka Wsr To Frozen Shoulder.there will be 2 group in the study ,in group A randomly selected and clinically diagnosed 20 patient of Avabhauka (Frozen Shoulder) .group A will be given intervention by Agnikarma Along With Ashwagandha Churna ,and 20 patient of group B randomly selected and clinically diagnose will be apply Dashamool Pratimarsh Nasya With Agnikarma And Ashwagandha Churna.trial will be conducted for a period of 28 day .follow up of the case will be done after completion of 1 month course on the basis of primary and secondary outcomes.The data will be analyzed scientifically and statiscally. |