| CTRI Number |
CTRI/2025/03/083329 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Shoulder pain is treated by Agnikarma in Ayurveda |
|
Scientific Title of Study
|
To Study The Efficacy Of Agnikarma As Analgesic In Frozen Shoulder Comparison To Tramadol
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharati Biswas |
| Designation |
PG Scholar |
| Affiliation |
Govt Ayurvedic college and Hospital jalukbari GHY 14 |
| Address |
Govt Ayurvedic college and Hospital jalukbari GHY 14
Govt Ayurvedic college and Hospital jalukbari GHY 14
Kamrup
ASSAM
7801014
India |
| Phone |
8638128061 |
| Fax |
|
| Email |
bharatibiswasgach@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namita Baishya |
| Designation |
Assistant professor shalya tantra department |
| Affiliation |
Govt Ayurvedic college and Hospital jalukbari GHY 14 |
| Address |
Govt Ayurvedic college and hospital jalukbari GHY 14
Govt Ayurvedic college and Hospital jalukbari GHY 14
Kamrup
ASSAM
7801014
India |
| Phone |
8011522100 |
| Fax |
|
| Email |
nomita3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namita Baishya |
| Designation |
Assistant professor shalya tantra department |
| Affiliation |
Govt Ayurvedic college and Hospital jalukbari GHY 14 |
| Address |
Govt Ayurvedic college and hospital jalukbari GHY 14 Assam
Govt Ayurvedic college and Hospital jalukbari GHY 14
Assam
ASSAM
7801014
India |
| Phone |
8011522100 |
| Fax |
|
| Email |
nomita3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurvedic college and hospital jalukbari Assam India
Pin 781014
India
|
|
|
Primary Sponsor
|
| Name |
Govt Ayurvedic college and Hospital jalukbari GHY |
| Address |
Govt Ayurvedic college and Hospital jalukbari GHY Assam 781014 |
| 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 Namita Baishya |
Govt Ayurvedic college and Hospital jalukbari GHY 14 |
OPD & IPD Of Shalya tantra department of Govt Ayurvedic college and hospital jalukbari
Kamrup
ASSAM |
8011522100
nomita3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee govt Ayurvedic college GHY 14 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M248||Other specific joint derangements,not elsewhere classified. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Agnikarma | (Procedure Reference: Su.su.12/10, Procedure details: 5 days including 3 sitting of Agnikarma
Follow up - 2 month)
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 selection of patient was done irrespective of sex and religion.
2 patient with classical signs and symptoms of Frozen shoulder i.e. pain, stiffness and restricted movement of shoulder joint.
3 patient age group of 16 and 70 years. |
|
| ExclusionCriteria |
| Details |
1 pain due to localised acute fracture.
2 pain related to cancer.
3 uncontrolled diabetes mellitus and hypertension.
4 subluxation or recurrent dislocation of the shoulder joint.
5 patients contraindicated for Agnikarma mentioned in sushruta samhita.
6 pregnant lady, elderly people, children. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in the symptoms of Frozen shoulder like pain , stiffness and restricted movement. |
5 days including 3 sitting of Agnikarma.Follow up - 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease / absent of the symptoms of Frozen shoulder. |
5 days including 3 sitting of Agnikarma. Follow up - upto 2 months after completion of treatment. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2025 |
| 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
|
Agnikarma is a safe , non invasive and para surgical procedure as mentioned by Acharya sushruta which is most effective for severe pain in skin, joints , muscles, ligaments ect. So, Agnikarma is effective in Frozen shoulder also.This is done compulsory part of post graduate course. Total number of patients to be studied is 30 with duration of 5 Days including 3 sitting of Agnikarma. |