| CTRI Number |
CTRI/2025/07/091700 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial to evaluate the efficacy of Viddhakarma (Ayurvedic technique of Needle Puncturing at specific points on the body) in the management of Frozen shoulder patients to evaluate its efficacy to resolve the symptoms of the disease. |
|
Scientific Title of Study
|
Comparative study of Viddhakarma and Agnikarma in the management of Avabahuk 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 Prathamesh Pramod Shetye |
| Designation |
PhD Scholar |
| Affiliation |
Yashwant Ayurvedic College PG Training and Research Centre, Kodoli. |
| Address |
Department of Shalyatantra, OPD No.02, Yashwant Ayurvedic College PG Training and Research Centre Kodoli, Taluka: Panhala, District: Kolhapur, Maharashtra, India.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9763751651 |
| Fax |
|
| Email |
drprathameshshetye@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivas Narasimha Turlapati |
| Designation |
Professor and HOD Shalyatantra Department |
| Affiliation |
Yashwant Ayurvedic College PG Training and Research Centre, Kodoli |
| Address |
Department of Shalyatantra, OPD No.02, Yashwant Ayurvedic College PG Training and Research Centre, Kodoli, Taluka:Panhala, District:Kolhapur, Maharashtra, India.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9503147698 |
| Fax |
|
| Email |
drsrinivast@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prathamesh Pramod Shetye |
| Designation |
PhD Scholar |
| Affiliation |
Yashwant Ayurvedic College PG Training and Research Centre, Kodoli |
| Address |
Department of Shalyatantra, OPD No.02, Yashwant Ayurvedic College PG Training and Research Centre, Kodoli, Taluka:Panhala, District:Kolhapur, Maharashtra, India.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9763751651 |
| Fax |
|
| Email |
drprathameshshetye@gmail.com |
|
|
Source of Monetary or Material Support
|
| MES Ayurved Mahavidyalaya, Lote, District: Ratnagiri, State: Maharashtra, India. Pincode: 415722 |
| Yashwant Ayurvedic College PG Training and Research Centre, Kodoli, Taluka: Panhala, District: Kolhapur, State: Maharashtra, India. Pincode: 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Prathamesh Pramod Shetye |
| Address |
Yashwant Ayurvedic College PG Training and Research Centre, Kodoli, Taluka: Panhala, District: Kolhapur, State: Maharashtra, India. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prathamesh Pramod Shetye |
MES Ayurved Mahavidyalaya, Lote |
Department of Shalyatantra, OPD No.10, MES Ayurved Mahavidyalaya, Lote, Ratnagiri, Maharashtra, India.
Ratnagiri
MAHARASHTRA |
9763751651
drprathameshshetye@gmail.com |
| Dr Prathamesh Pramod Shetye |
Yashwant Ayurvedic College PG Training and Research Centre, Kodoli. |
Department of Shalyatantra, OPD No.02, Yashwant Ayurvedic College PG Training and Research Centre, Kodoli, Taluka: Panhala, District: Kolhapur, Maharashtra, India.
Kolhapur
MAHARASHTRA |
9763751651
drprathameshshetye@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC MES Ayurved Mahavidyalaya, Lote |
Approved |
| IEC Yashwant Ayurvedic College, Kodoli. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Viddhakarma | (Procedure Reference: Sushrut Samhita, Procedure details: Viddhakarma using disposable needle no.26
Application of therapy on 0th, 7th 14th & 21st day)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushrut Samhita, Procedure details: Agnikarma using Tamra Shalaka
Application of therapy on 0th, 7th 14th & 21st day)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Avabahuk with symptoms like shoulder joint pain, restricted movements of shoulder and tenderness at shoulderjoint. |
|
| ExclusionCriteria |
| Details |
1. History of Neurogenic Shock or trauma or sight of blood 32
2. Skin infection at the place of puncture
3. History of injury, fracture to upper limb
4. Any type of comorbidity like diabetes, hypertension etc.
5. Patient on anticoagulant medications
6. Pregnant Women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative study of Viddhakarma and Agnikarma in the management of Avabahuk W.S.R.to Frozen shoulder |
28 days
Application of therapy on 0th, 7th, 14th and 21st day.
Follow up on 7th, 14th, 21st and 28th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study in detail about Sandhigata Vata affecting Amsa Sandhi from Ayurvedic Texts
2. To study in detail about Frozen Shoulder.
3. Literature review of Viddhakarma. |
28 days
Application of therapy on 0th, 7th, 14th and 21st day
Follow up on 7th, 14th, 21st and 28th day. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
04/08/2025 |
| 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="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
|
Title: Comparative study of Viddhakarma and Agnikarma in the management of Avabahuk W.S.R. to Frozen shoulder.
Null Hypothesis (H0) :- Viddhakarma not significantly effective in the management of Avabahuk than Agnikarma.
Alternative Hypothesis(H1) :- Viddhakarma significantly effective in management of Avabahuk than Agnikarma.
Study design:- Open Randomized Controlled Clinical Trial.
Inclusive Criteria: 1) Diagnosed cases of Avabahuk with symptoms like shoulder joint pain, restricted movements of shoulder, tenderness. 2) Age group between 18-65 years. 3) Selection shall be irrespective of sex, religion, socio- economic status.
Exclusive Criteria: 1. Diabetic Mellitus (>200 mg/dl), HTN (>140/100 mmHg), Malignancy, HIV, HBsAG 2.Cardiac diseases 3.Anemia 4.Pregnancy 5.Bleeding disorders 6.Pitta Prakruti 7.Fracture of shoulder joint
Withdrawal Criteria: 1) Patients who request to withdraw 2) Developing diseases mentioned in the exclusion criteria after enrollment. 3) Out-migrating or temporarily going out, missing the scheduled of procedure 4) During course of clinical study if any serious complications occurs which requires urgent treatment. 5) Symptomatic relief. Note: Patients discontinuing the treatment will be replaced by patients fulfilling the criteria of inclusion.
Sample Size:- Total 100 ( 50 for each group)
Patients coming in IPD and OPD of Shalyatantra department of research institute hospital and working hospital, with complaint of Avabahuk.
Group A - Trial group - Patients will be treated by Viddhakarma with disposable needle no. 26, 0.45mm in breadth, 13mm in length.
Group B - Control group - Patients will be treated by Agnikarma with Tamra Shalaka.
Study Duration - 18 Months
Duration of Treatment - 28 Days
Application of therapy on 0th, 7th, 14th and 21st day. Follow up on 7th, 14th, 21st and 28th day. Assessment on each follow up 7th, 14th, 21st and 28th day.
Subjective Parameters: 1. Painful shoulder movements 2. Shoulder Stiffness 3. Tenderness 4. Tingling Numbness
Objective Parameters: 1. Pain measurement with Visual Analogous Scale 2. Goniometric Scale Readings to assess shoulder movements.
Result and inference will be drawn on the basis of readings obtained before and after treatment by using the appropriate statistical methods.
|