| CTRI Number |
CTRI/2023/09/058091 [Registered on: 27/09/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Agnikarma with Loha Shalaka in Avbahuka |
|
Scientific Title of Study
|
A Randomized controlled clinical study to evaluate the effects of Agnikarma with loha shalaka 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 DIMPLE ASHOK BORICHA |
| Designation |
PG SCHOLAR |
| Affiliation |
YASHWANT AYURVEDIC MEDICAL COLLEGE |
| Address |
YASHWANT AYURVEDIC MEDICAL COLLEGE PGT AND RC KODOLI, DEPARTMENT SHALYATANTRA OPD NO-4 , KODOLI,DIST-KOLHAPUR- MAHARASHTRA-416114
Mumbai
MAHARASHTRA
400088
India |
| Phone |
8169789516 |
| Fax |
|
| Email |
payal12boricha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrinivas Turlapati |
| Designation |
HOD, PG GUIDE, Shalyatantra department |
| Affiliation |
YASHWANT AYURVEDIC MEDICAL COLLEGE |
| Address |
Yashwant Ayurvedic Medical college PGT and RC Kodoli, shalyatantra department opd no-4, kodoli dist-kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9503147698 |
| Fax |
|
| Email |
drsrinivast@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dimple Ashok Boricha |
| Designation |
PG SCHOLAR |
| Affiliation |
YASHWANT AYURVEDIC MEDICAL COLLEGE |
| Address |
Yashwant Ayurvedic Medical college PGT and RC kodoli, shalyatantra department, opd no-4 ,Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8169789516 |
| Fax |
|
| Email |
payal12boricha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic Medical College PGT and RC kodoli Dist Kolhapur Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Dimple Ashok Boricha |
| Address |
Yashwant Ayurvedic Hospital, kodoli, Kolhapur |
| 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 Dimple Ashok Boricha |
Yashwant Ayurvedic Medical College PGT and RC Kodoli |
Shalyatantra department opd no-4, kodoli, Dist-Kolhapur
Kolhapur
MAHARASHTRA |
8169789516
payal12boricha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 | Procedure | - | agnikarma (viShopakramaH), अगà¥à¤¨à¤¿à¤•à¤°à¥à¤®Â (विषोपकà¥à¤°à¤®à¤ƒ) | (Procedure Reference: SUSHRUT, Procedure details: Patient is made to sit in the sitting position the shoulder is cleaned properly then the most painful & tender points are marked with the marker then the shalaka is made red hot using gas stove,after the shalaka is red hot then agnikarma is performed in bindu manner 12-15 dots,As soon as samyak twak dagdh vrana is made appropriate precaution were taken that no asamyak daghd vrana is formed)
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1-Patient with complaints of pain in the shoulder region,painful movement,restricted movements
2-Clinical symptoms of cervical spondylosis with or without radiological changes
3-diabetic patients with controlled blood sugar levels
4-Hypertensive patients with controlled BP levels
5-patients without any cardiac disease |
|
| ExclusionCriteria |
| Details |
1-Patients with Shoulder dislocation
2-Patients with Rheumatoid arthritis
3-Pregnant females
4-Patients with any congenital deformity
5-Patients with traumatic injuries
6-Patients with infection of bone and gross bony deformity
7-patients had undergone any surgical procedure
8-patients above 70 years of age |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1-Decrease in pain of the shoulder
2-Range of shoulder movement improved |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1- DECREASE IN PAIN OF SHOULDER
2-RANGE OF MOVEMENT OF SHOULDER IMPROVED |
7 DAYS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/10/2023 |
| 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
|
THIS STUDY IS A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECTS OF AGNIKARMA WITH LOHA SHALAKA IN AVABAHUKA WITH SPECIAL REFERENCE TO FROZEN SHOULDER THE OBSERVATION WILL BE DRAWN ON THE BASIS OF TREATMENT GIVEN |