| CTRI Number |
CTRI/2025/08/093749 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Trayodashang Guggulu and Viddha Karma in Treating Frozen Shoulder (Stage 2) |
|
Scientific Title of Study
|
Evaluation of the efficacy of Trayodashang Guggulu with and without Viddha Karma in the Management of Avabahuka (Frozen Shoulder – Stage 2) – A Randomized controlled Trial |
| 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 Akruti Anil Bhange |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital And Research Centre |
| Address |
Room no 30 Department Of Kayachikitsa Mahatma Gandhi Ayurved
College Hospital And Research Centre Salod hirapur Wardha
Maharashtra Salod hirapur wardha
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7350492113 |
| Fax |
|
| Email |
akrutibhange24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayuri Amol Deshpande |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital And Research Centre |
| Address |
Room no 30 Department Of Kayachikitsa Mahatma Gandhi Ayurved
College Hospital And Research Centre Salod hirapur Wardha
Maharashtra Salod hirapur wardha
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9130292949 |
| Fax |
|
| Email |
mayuri.deshpande@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akruti Anil Bhange |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital And Research Centre |
| Address |
Room no 30 Department Of Kayachikitsa Mahatma Gandhi Ayurved
College Hospital And Research Centre Salod hirapur Wardha
Maharashtra Salod hirapur wardha
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7350492113 |
| Fax |
|
| Email |
akrutibhange24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 30 Department Of Kaychikitsa Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Hirapur Wardha Maharashtra 442001 India |
|
|
Primary Sponsor
|
| Name |
Dr Akruti Anil Bhange |
| Address |
Room No 30 Department Of Kaychikitsa Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Hirapur Wardha Maharashtra 442001 India |
| 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 Akruti Anil Bhange |
Mahatma Gandhi Ayurved College Hospital And Research Centre |
Room No 30 Department Of Kaychikitsa Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Hirapur Wardha Maharashtra 442001 India
Wardha
MAHARASHTRA |
7350492113
akrutibhange24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MGACH&RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trayodashang guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 250(mg), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | Viddhakarma | (Procedure Reference: Sushrut Samhita, Procedure details: )
| | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trayodashang guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 250(mg), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 30–60 years
Clinical signs and symptoms of Avabahuk (frozen shoulder stage - 2)
Disease duration up to 1 year
Consent form |
|
| ExclusionCriteria |
| Details |
Diagnosed patients of Diabetes mellitus with complications
Trauma, fractures, infections of shoulder joint
Patients on corticosteroids or surgery
Severe systemic illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To assess the effect of
TrayodashangGuggulu in management ofAvabahuk.2
To evaluate the combined effect of Viddha Karma and TrayodashangGuggulu.
3To compare pain relief, mobility, and functional outcomes.
|
1)Day 1 (Basaeline)
2)7th 14th 28 th day
3)Follow up at 37th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
22/09/2025 |
| 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 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
|
The volunteers will be informed about the study protocol. willing participants will be randomly selected as per computerized method . clinical research format will be prepared and validated. prior to the study approval will be taken from IEC, MGACHRC Salod hirapur wardha and CTRI registeration wil be done. After selection, participants will be tested individually and selected according to selection criteria. they will be divided into two groups the trial is a parallel group, randomized Open labelled standard controlled trial. |