| CTRI Number |
CTRI/2025/04/085050 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to check the combined effect of prasarini taila pratimarsha nasya and prasarini capsules in apabahuka.Frozen shoulder |
|
Scientific Title of Study
|
An open label single arm clinical study on the combined effect of prasarini taila pratimarsha nasya and prasarini capsule in apabahuka.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 Prajwal Kumar B Shivanagoudar |
| Designation |
PG scholar Department of Kayachikitsa |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road thanniruhalla Hassan |
| Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9611641481 |
| Fax |
|
| Email |
kumarprajwal640@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasantha B |
| Designation |
Associate Professor Department of Kayachikitsa |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road thanniruhalla Hassan |
| Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9886213224 |
| Fax |
|
| Email |
drvasantha225@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasantha B |
| Designation |
Associate Professor Department of Kayachikitsa |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road thanniruhalla Hassan |
| Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road thanniruhalla Hassan
KARNATAKA
573201
India |
| Phone |
9886213224 |
| Fax |
|
| Email |
drvasantha225@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of Ayurveda and HospitalBM road thanniruhalla Hassan karnataka 573201 |
|
|
Primary Sponsor
|
| Name |
SDM college of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road thanniruhalla Hassan karnataka 573201 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road thanniruhalla Hassan |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road thanniruhalla Hassan |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prajwal Kumar B Shivanagoudar |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road thanniruhalla Hassan |
Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road thanniruhalla Hassan 573201 karnataka
Hassan
KARNATAKA |
9611641481
kumarprajwal640@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: bhavaprakasha, Procedure details: instillation of 2 bindu of prasarini nasya taila in both nostrils)
(1) Medicine Name: prasarini capsules, Reference: bhavaprakasha, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Consent Subjects aged between 30-70 years
Subjects with 1 year chronicity
Subjects fit for Nasya karma
Subjects of either gender irrespective of caste occupation religion socioeconomic status
Subjects who are willing to participate and sign the informed form
|
|
| ExclusionCriteria |
| Details |
amsa shosha
subjects presenting with fracture or dis location of shoulder joint
uncontrolled Diabetes Mellitus and hypertension
pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To rule out impact of prasarini taila preatimarsha nasya in Apabahuka |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To rule out impact of prasarini capsules in Apabahuka |
4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/04/2025 |
| 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="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
|
Study title is An open label single arm clinical study on the combined effect of Prasarini taila pratimarsha nasya and prasarini capsule in Apabahuka{Frozen Shoulder} is an interventional study to assess the combined effect of the prasarini in the form of nasya and capsule from the age group 30 to 70 years without any complications like uncontrolled DM and Hypertension with the samole size of 30subjects and study duration is 1 and half years. the data collecting method is by case report form and data analysis will be done with the help of SPSS software |