| CTRI Number |
CTRI/2025/03/083298 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Krishna Mrittika Lepa and Vatghana Lepa in Treating Frozen Shoulder |
|
Scientific Title of Study
|
A Comparative study to evaluate the efficacy of Krishna Mrittika Lepa and Vatghana Lepa in Avabahuka w.s.r. 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 Umesh Shukla |
| Designation |
HOD of Swasthavritta Department |
| Affiliation |
Rajiv Gandhi Government PG Ayurvedic College and Hospital Paprola |
| Address |
Room No. 401 Yog Kendra Geriatric Building (Top Floor) PG Department of Swasthavritta Rajiv Gandhi Government PG Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018242861 |
| Fax |
|
| Email |
dr.umeshshukla1969@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitish Bhatt |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Government PG Ayurvedic College and Hospital, Paprola |
| Address |
Room No. 405 Yog Kendra Geriatric Building (Top Floor) PG Department of Swasthavritta Rajiv Gandhi Government PG Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7807177649 |
| Fax |
|
| Email |
nkb1999bhatt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh Shukla |
| Designation |
HOD of Swasthavritta Department |
| Affiliation |
Rajiv Gandhi Government PG Ayurvedic College and Hospital Paprola |
| Address |
Room No. 401 Yog Kendra Geriatric Building (Top Floor) PG Department of Swasthavritta Rajiv Gandhi Government PG Ayurvedic College and Hospital Paprola
HIMACHAL PRADESH
176115
India |
| Phone |
7018242861 |
| Fax |
|
| Email |
dr.umeshshukla1969@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Government PG Ayurvedic College and Hospital Paprola (HP) 176115 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Government PG Ayurvedic College and Hospital Paprola |
| Address |
PG Department of Swasthavritta
Rajiv Gandhi Government PG Ayurvedic College and Hospital
Paprola (HP) |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nitish Bhatt |
Rajiv Gandhi Government PG Ayurvedic College and Hospital Paprola |
Room No. 405 Yog Kendra Geriatric Building (Top Floor) PG Department of Swasthavritta Rajiv Gandhi Government PG Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH |
7807177649
nkb1999bhatt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Etics Committee (Human) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M750||Adhesive capsulitis of shoulder. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhar Samhita Uttar Khand, Procedure details: First of all, Swedana will be done on the affected shoulder joint.
After the Swedana process, Mrittika Lepa will be applied over the affected shoulder joint.
After application of Mrittika Lepa, it will start to dry & cracks will start to appear in it. then it will be removed.)
| | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Su. S.- 18/04, Procedure details: The fine powder obtained as filtrate will be further mixed with Nimbu Phala Swarasa to prepare Lepa.
Lepa will be applied against the hair follicular direction.
Vatghana Lepa will have thickness of Chaturbhag Angula Pramana.
First of all, Swedana will be done for 20 minutes on the local affected area.
After the Swedana process, Vatghana Lepa will be applied over the affected shoulder joint.
After application of Vatghana Lepa, when it will start to dry, cracks start to appear in it. That will be the time to remove Lepa, & the area will be cleaned with lukewarm water.)
(1) Medicine Name: Vatghana Lepa, Reference: Chakradatt- 22/83, Route: Topical, Dosage Form: Lepa Churna, Dose: 15(g), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
i. Patients having typical clinical features pertaining to Avabahuka with special reference to frozen shoulder.
ii. Patients willing for the trial.
iii. Age group of 40-70 years of either sex.
|
|
| ExclusionCriteria |
| Details |
i. Patients below 40 years and above 70 years of age.
ii. Patient unwilling to participate in the trial.
iii. pregnant and lactating woman.
iv. Patients suffering from tubercular arthritis, rheumatoid arthritis, gout, and inflammatory and autoimmune conditions.
v. Degenerative disorders associated with metastasis or life-threatening disorders.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To relieve symptoms of Avabahuka (Frozen shoulder) |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the more effective treatment for Avabahuka (Frozen Shoulder) among Krishna Mrittika Lepa and Vatghana Lepa |
21 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 |
|
Date of First Enrollment (India)
|
21/04/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To assess the effect of Krishna
Mrittika Lepa and
Vatghana Lepa in Avabahuka (Frozen Shoulder). The procedure will be done daily for 21 days. The purpose of this trial is to relieve the frozen shoulder and to search for a most effective and simple
treatment for frozen shoulder |