| CTRI Number |
CTRI/2025/04/085665 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To examine the effect of Nasya with 1ml of Sairiya taila application in 35 participants (both male and female) of age group between 18 to 60 year with sign of frozen shoulder. |
|
Scientific Title of Study
|
A clinical study of role of Nasya karma with Sairiya taila in the management of 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 |
Swati Ashok Joshi |
| Designation |
BAMS PG scholar (Panchakarma) |
| Affiliation |
LKR Ayurvedic college and Research Centre |
| Address |
Panchakarma Department, ground foor,room number 3,LKR hospital P2 MIDC area Shendri mal, Gadhinglaj,Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8668850070 |
| Fax |
|
| Email |
swatijoshi848@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Shirsat |
| Designation |
BAMS MD PANCHAKARMA |
| Affiliation |
LKR Ayurvedic college and Research Centre |
| Address |
Panchakarma Department, ground foor,room number 3,LKR hospital P2 MIDC area Shendri mal, Gadhinglaj,Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7798861414 |
| Fax |
|
| Email |
namishirsat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swati Ashok Joshi |
| Designation |
BAMS PG Scholar (Panchakarma) |
| Affiliation |
LKR Ayurvedic college and Research Centre |
| Address |
Panchakarma Department, ground foor,room number 3,LKR hospital P2 MIDC area Shendri mal, Gadhinglaj,Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8668850070 |
| Fax |
|
| Email |
swatijoshi848@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic college and Research center,Tal- gadhinglaj,Dist- Kolhapur,State-Maharashtra,Country- India,Pin code-416502 |
|
|
Primary Sponsor
|
| Name |
Swati Ashok Joshi |
| Address |
A-402 Vedant Heights mohammadwadi,near mohammadwadi police chowki, Dist-Pune, State-Maharashtra, Country-India, Pin code-411060 |
| 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 Swati Ashok Joshi |
LKR Ayurvedic college and Research center Gadhinglaj |
Panchakarma Department, ground foor, room number 3,LKR hospital P2 MIDC area Shendri mal, Gadhinglaj, Kolhapur-416502
Pune
MAHARASHTRA |
8668850070
swatijoshi848@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| L.K.R Ayurvedic college and Research center,Gadhinglaj |
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 | Drug | Classical | | (1) Medicine Name: Sairiya taila, Reference: Chakradatta Vatavyadhi Chikitsha 22/94-95, Route: Nasal, Dosage Form: Taila, Dose: 1(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Nasya karma given for continuous 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical symptoms i.e Pain, Stiffness and Range of affected shoulder movements as of Avabahuka and Nasya Arha patients. |
|
| ExclusionCriteria |
| Details |
Pregnant women, lactating women, fractured and dislocation in the shoulder region, patients with systemic disorders which may cause interference in the treatment of study,patients unfit for nasya karma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Sairiya Taila nasya in Avabahuka patients |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study Sairiya taila
To study Avabahuka
To study Nasya karma |
7 days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
06/05/2025 |
| 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
|
This is a clinical study of role of Nasya karma with Sairiya taila in the management of Avabahuka with special reference to Frozen shoulder. Total 35 patients of age 18 to 60 years of both sex will be selected and Sairiya taila nasya is given for 7 days. Data will be analysed and appropriate statistical test will be applied,result will be presented. |