| CTRI Number |
CTRI/2022/10/046119 [Registered on: 03/10/2022] Trial Registered Prospectively |
| Last Modified On: |
02/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Lepa applied on stiff wrist joint |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Krishna Mrittika Chikitsa and certain Yogic Practices in the management of post traumatic stiffness of wrist joint |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tek Chand Thakur |
| Designation |
Professor, Department of Swasthavritta |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra |
| Address |
Room number 411 Swasthavritta department anatomy block Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola, Kangra
Room no 411 swasthavritta department anatomy block Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital,Paprola Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418019725 |
| Fax |
|
| Email |
tcthakur2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tek Chand Thakur |
| Designation |
Professor, Department of Swasthavritta |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra |
| Address |
Room no 411 swasthavritta department Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola, Kangra
Room no 411 swasthavritta department anatomy block Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital,Paprola Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418019725 |
| Fax |
|
| Email |
tcthakur2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tek Chand Thakur |
| Designation |
Professor, Department of Swasthavritta |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra |
| Address |
Room no 411 swasthavritta department anatomy block Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola, Kangra
Room no 411 swasthavritta department anatomy block Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital,Paprola Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418019725 |
| Fax |
|
| Email |
tcthakur2@gmail.com |
|
|
Source of Monetary or Material Support
|
| RGGPG Ayurvedic College And Hospital Paprola District Kangra |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra |
| Address |
Department of Swasthavritta, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Tek Chand Thakur |
Department of Swasthavritta, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaurav Dhiman |
RGGPG Ayurvedic Hospital |
Swasthavritta Department Anatomy Block RGGPG Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH |
8219575341
gaurav4321dhiman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEChumanRggpgayurvediccollegepaprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M199||Osteoarthritis, unspecified site, (2) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhaishajya ratnavali Shool Roga Adhyaya 30, Sharanghdhar Samhita uttar khand 11/7, Sushruta Samhita Kalpa 1/57, Bhavprakash 8/156., Procedure details: Procedure details:In group one Krishna mrittika lepa will be applied on the affected wrist joint after hot water fomentation along with yogic practices (Sukshama Vyayama).In group two only Krishna mrittika lepa will be applied on the affected wrist joint after hot water fomentation.
Hot water fomentation for 15 minutes.
Krishna mrittika lepa for 45 minutes.
Yogic practices (Sukshama Vyayama) for 20 minutes.)
| | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhaishajya Bhaishajya ratnavali Shool Roga Adhyaya 30, Sharanghdhar Samhita uttar khand 11/7, Sushruta Samhita Kalpa 1/57, Bhavprakash 8/156, Procedure details: Procedure details:In group one Krishna mrittika lepa will be applied on the affected wrist joint after hot water fomentation along with yogic practices (Sukshama Vyayama).In group two only Krishna mrittika lepa will be applied on the affected wrist joint after hot water fomentation.
Hot water fomentation for 15 minutes.
Krishna mrittika lepa for 45 minutes.
Yogic practices (Sukshama Vyayama) for 20 minutes.)
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to undergo trial and having history of trauma.
Patients having clinical features pertaining to post traumatic stiffness of wrist joint like pain,stiffness,swelling,tenderness. |
|
| ExclusionCriteria |
| Details |
Patients not willing to undergo trial. Patients having no history of trauma. Patients below 40 years and above 70 years.
Patients with other associated injuries. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relieve in sign and symptoms like pain,stiffness,swelling,tenderness,range of motion. |
21 days (3 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete remission of signs and symptoms. |
Follow up total three ( Each at an interval of one week ) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/10/2022 |
| 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="0"
Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Effect of krishna mrittika lepa along with yogic practices will be assessed in group A and in group B only krishna mrittika lepa will be applied. Purpose of trial is to provide relief from signs and symptoms of post traumatic stiffness of wrist joint . Procedure includes purvakarma - svedana (hot water fomentation), pradhana karma - krishna mrittika application (black soil pack application) on affected wrist joint, paschat karma- yogic practices will be done . |