| CTRI Number |
CTRI/2025/03/081917 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| 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
|
A Clinical trail on the effect of Mashadi taila yoga after Ksheerabala taila Nasya in Avabahuka vis-a-vis Frozen shoulder(Shoulder pain) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study on the effect of Mashadi taila yoga after Ksheerabala taila Nasya in Avabahuka vis-a-vis 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 Bhoomika R |
| Designation |
PG Scholar |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
Room No 5, Department of Kayachikitsa, Department of PG Studies Division, Sushrutha Ayurvrdic Medical College and Hospital Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
9113980965 |
| Fax |
|
| Email |
bhoomika11199@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vajrala Venkat Ram Reddy |
| Designation |
Professor and HOD |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
Room No 5, Department of Kayachikitsa, Department of PG Studies Division, Sushrutha Ayurvrdic Medical College and Hospital Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
8099993599 |
| Fax |
|
| Email |
ramreddyv9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhoomika R |
| Designation |
PG Scholar |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
Room No 5, Department of Kayachikitsa, Department of PG Studies Division, Sushrutha Ayurvrdic Medical College and Hospital Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk
Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
9113980965 |
| Fax |
|
| Email |
bhoomika11199@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa, Department of PG Studies Division, Sushrutha Ayurvrdic Medical College and Hospital Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk, Bangalore, Karnataka, India-
560105 |
|
|
Primary Sponsor
|
| Name |
Dr Bhoomika R |
| Address |
Sushrutha Ayurvrdic Medical College and Hospital Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk, Bangalore, Karnataka, India- 560105 |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sushrutha Ayurvrdic Medical College and Hospital |
Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk, Bangalore, Karnataka, India- 560105 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhoomika R |
Sushrutha Ayurvedic Medical College and Hospital |
Room No 4, Department of Kayachikitsa, Out Patient Department, Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk, Bangalore, KARNATAKA
Bangalore
KARNATAKA |
9113980965
bhoomika11199@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SAMC and H |
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: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mashadi taila yoga , Reference: Bhavaprakasha Madhyama Khanda Vatavyadhi Adhikara , Route: Oral, Dosage Form: Taila, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Ksheera ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects irrespective of genders between age group of 30-60 years
Subjects fulfilling the diagnostic criteria
Subjects suitable for Nasya karma
Subjects with informed consent |
|
| ExclusionCriteria |
| Details |
Subjects with Autoimmune diseases.
Subjects suffering from Parkinson’s disease.
Subjects suffering from respiratory disease like Bronchial asthma, Allergic rhinitis.
Subjects with other major systemic disorders which would interfere with present study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms of Avabahuka assessed by subjective criteria |
8th day and 22nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjects condition assessed by objective criteria |
8th and 22nd day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
18/03/2025 |
| 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="2"
Months="0"
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
|
This study is randomized, comparative clinical trail to evaluate the efficacy of Mashadi taila yoga 12ml twice daily for 15 days, after Nasya karma with ksheerabala taila for 7 days in Group A with minimum of 15 subjects, Nasya karma with ksheerabala taila for 7 days and is under observation for 15 days in Group B with minimum of 15 subjects in the management of Avabahuka vis-a-vis Frozen shoulder for a period of 22 days. The primary outcome is reducing the symptoms of subjects and secondary outcome is improving the condition of the subject. |