| CTRI Number |
CTRI/2025/07/090971 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Patra pinda sweda along with shoulder joint mobilization in avabahuk. |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial To Study The Adjuvant Effect of Patra Pinda Sweda Along With Shoulder Joint Mobilization 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 Supriya Vitthal Temkar |
| Designation |
Post graduate student |
| Affiliation |
SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON. |
| Address |
SMBT ayurveda college and hospital - hospital building ,opd no 9, SMBT Dhamangaon , Igatpuri,Nashik 422403, Maharashtra , India.
SMBT ayurveda college and hospital - hospital building ,opd no 9, SMBT Dhamangaon , Igatpuri,Nashik 422403, Maharashtra , India.
Nashik
MAHARASHTRA
422403
India |
| Phone |
940573390 |
| Fax |
|
| Email |
supriyatemkar.svt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Mandalkar |
| Designation |
Head of department in department of panchkarma |
| Affiliation |
SMBT college and hospital, Dhamangaon , Igatpuri,Nashik - 422403, Maharashtra , India. |
| Address |
SMBT ayurveda college and hospital - hospital building ,opd no 9, SMBT Dhamangaon , Igatpuri,Nashik 422403, Maharashtra , India.
SMBT ayurveda college and hospital - hospital building ,opd no 9, SMBT Dhamangaon , Igatpuri,Nashik 422403, Maharashtra , India.
Nashik
MAHARASHTRA
422403
India |
| Phone |
9604633832 |
| Fax |
|
| Email |
vdpramod31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriya Vitthal Temkar |
| Designation |
Post graduate student |
| Affiliation |
SMBT AYURVED COLLEGE AND HOSPITAL DHAMANGAON, IGATPURI, NASHIK. |
| Address |
SMBT ayurveda college and hospital - hospital building ,opd no 9, SMBT Dhamangaon , Igatpuri,Nashik 422403, Maharashtra , India.
SMBT ayurveda college and hospital - hospital building ,opd no 9, SMBT Dhamangaon , Igatpuri,Nashik 422403, Maharashtra , India.
Nashik
MAHARASHTRA
422403
India |
| Phone |
9405763390 |
| Fax |
|
| Email |
supriyatemkar.svt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of panchakarma SMBT Ayurved college and hospital Dhamangaon Igatpuri Nasik 422403 |
|
|
Primary Sponsor
|
| Name |
Dr Supriya Vitthal Temkar |
| Address |
Opd no 19 department of panchkarma SMBT ayurved college and hospital dhamangaon 422403,igatpuri, nashik. |
| 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 Supriya vitthal temkar |
SMBT Ayurved college and hospital |
OPD no 19 Department of panchakarma SMBT Ayurved college and hospital Dhamangaon Igatpuri Nasik 422403
Nashik
MAHARASHTRA |
9405763390
-
supriyatemkar.svt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
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 | - | piNDasvedaH, पिण्डस्वेदः | (Procedure Reference: Reference for patrapinda sweda Dr Pramod mandalkar Theraputic procedure of panchakarma minar panchakarma procedure chapter 31 patra pinda sweda page no 157 Rudra publication 2022, Procedure details: Pradhanakarma
Position of Patient Depending upon comfort of patient, the area that is to be subjected to Swedana can be easily approached by the therapist.
It will be performed in sitting & lying down in supine position, prone position, right lateral position, or left lateral position depending upon shoulder involved.
Application of heat Before the heat is applied, the temp of bolus would be confirmed by the therapist by touching it on the dorsum of his hand.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Shoulder joint mobilization | Shoulder joint mobilization with Mulligan techniquewill reposition
a joint to enable proper motion while taking that joint through
pain free passive and active range of motion Mulligan
technique combines sustained manual application of gliding
force to a joint with aim of repositioning the bone positional
false with concurrent physiological motion of the joint either
performed actively by patient or passively by the therapist in
pain free range |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having classical signs and symptoms of Avabahuka like pain, stiffness and Restricted Range of motion of shoulder joint.
2. Gender- patients of all genders
3. Age-between years 35-70yrs
4. Economic status-All
5. 2nd and 3rd stage of Frozen shoulder i.e. 4 month to 42 months. |
|
| ExclusionCriteria |
| Details |
1.. Patients with other joint disorder which does not relates to Avabahuka will be excluded.
2. patients with traumatic, infective, neoplastic joint and cardiovascular disease.
3. Patients having congenital structural disorder will be excluded.
4. Patient having any type of arthritis, developed a painful stiff shoulder after a severe trauma to upper extremity, Previous fractures or dislocations of the shoulder complex, Rotator cuff tendinitis or tear, Previous intra-articular injection or surgical release and Complex regional pain syndrome Will be excluded from the study.
5. patients with 1st stage of Frozen shoulder.
6. Patients with diabetes mellitus. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Patrapinda sweda along with shoulder joint mobilization for 7 days in sign and symptoms of avabahuk by the comparison of the score of clinical evaluation |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Whether the trial group stands in comparison to control group in reduction of signs and symptoms of Avabahuka. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
30/07/2025 |
| 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) |
Open to Recruitment |
|
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
|
The population based study from India shows prevalence of Avabahuka is 10%. It is one of the disease which is painful and affects normal routine of life. So there is a need to find an alternative solution of this problem. Present study of randomized controlled trial will be carried out to study the efficacy of patrapindasweda along with shoulder joint mobilization in avabahuka . For present study subjects between age group 35-70 years will be taken irrespective of the religion, gender, socioeconomic status. Total sample size taken is 72 and patients will be taken for the study with 36 patients in Group A(trial group) and 36 patients in Group B(control group) . Patrapinda sweda along with shoulder joint mobilization is taken in group A(trial group) and shoulder joint mobilization is taken for Group B(control group). Procedure will be done for 7 days and follow up will be taken on 14th day. All SOP will be followed. All the findings will be entered in case record form. Observations will be drawn before, during and after treatment. Result will be drawn with the help of statistical method. Discussion will be done on the basis of observations. Summary will be drawn .Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased. |