| CTRI Number |
CTRI/2026/03/106439 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see which of the two nasal treatments works better in frozen shoulder |
|
Scientific Title of Study
|
A randomised comparative clinical study to evaluate the efficacy of marsha nasya with Nirgundi taila and Parinnatakeriksheeradi taila in Apabahuka w.s.r. Adhesive Capsulitis. |
| 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 Padmaja P Deshpande |
| Designation |
Associate professor |
| Affiliation |
SJG ayurvedic medical college PGstudies research centre and hospital |
| Address |
Panchakarma room no 7 Panchakarma department Jain AGM Ayurvedic medical college and medical hospitl varur
Dharwad
KARNATAKA
581207
India |
| Phone |
9449646106 |
| Fax |
|
| Email |
drsandyaghalagi1978@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Hakkandi |
| Designation |
Professor and HOD |
| Affiliation |
SJG ayurvedic medical college PGstudies research centre and hospital |
| Address |
Panchakarma room no 2 panchakarma department
Shree jadadguru gavisiddheshwar ayurvedic medical college post graduate studies research centre and hospital gavimath campus koppal
Koppal
KARNATAKA
583231
India |
| Phone |
9448609362 |
| Fax |
|
| Email |
sureshhakkandi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Padmaja P Deshpande |
| Designation |
Associate professor |
| Affiliation |
SJG ayurvedic medical college PGstudies research centre and hospital |
| Address |
Panchakarma room no 7 Panchakarma department Jain AGM Ayurvedic medical college and medical hospitl varur
Dharwad
KARNATAKA
581207
India |
| Phone |
9449646106 |
| Fax |
|
| Email |
drsandyaghalagi1978@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Padmaja P Deshpande |
| Address |
Jain AGM Ayurvedic medical college and hopsital varur |
| 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 Padmaja P Deshpande |
JAGMAMCH varur and SJG AMC koppal |
panchakarma departament room no 07
Jain AGM ayurvedic medical college and hospital varur
Dharwad
KARNATAKA |
9449646106
drsandyaghalagi1978@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SJGAMC Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M953||Acquired deformity of neck. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nirgundi taila , Reference: carak samhita, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 27 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: parinata keriksheeradi taila, Reference: sahasrayogam, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 27 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1Subjects presenting with classical clinical features of Avabahuka
2Subjects with chronicity of disease pertaining from 3 months to 3 years.
3 Subjects between the age group of 18-60 years irrespective of gender.
4Subjects fit for Nasya.
5Diabetic patients whose blood sugar levels are under control. |
|
| ExclusionCriteria |
| Details |
Apabahuka patients suffering from
1Autoimmune disorders like SLE, RA
2 Respiratory disorders like Bronchial asthma, Allergic bronchitis
3Post Traumatic injuries, Dislocation of Shoulder joint.
4Pregnant and lactating women
5Cervical spondylitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the therapeutic effect of Nirgundi Taila Nasya and Parinata Keraksheeradi Taila Nasya in the management of Avabahuka, based on improvement in clinical symptoms and functional parameters. |
study duration 27days
follow up on eighteen and twenty seventh day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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)
|
04/05/2026 |
| 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="5"
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
|
The present study is a randomized comparative clinical trial designed to evaluate the efficacy of Marsha Nasya with Nirgundi Taila and Parinata Keriksheeradi Taila in the management of Avabahuka (Adhesive Capsulitis / Frozen Shoulder). Avabahuka, a Vata-Kaphaja disorder, is characterized by shoulder pain, stiffness, and restricted movements, significantly impairing daily activities and quality of life. The condition closely resembles adhesive capsulitis described in contemporary medicine, affecting approximately 2–5percentage of the general population, predominantly between 40–60 years of age.
Ayurveda advocates Nasya Karma as a principal line of management for diseases of the urdhvajatrugata region, including Avabahuka. Classical texts recommend Nasya and snehana therapies to alleviate vitiated Vata and Kapha, restore joint mobility, and relieve pain. Based on these principles, the present study aims to compare the therapeutic effects of Nirgundi Taila Nasya and Parinata Keriksheeradi Taila Nasya.
A total of 100 patients diagnosed with Avabahuka will be randomly allocated into two groups of 50 each. Group A will receive Nirgundi Taila Nasya, while Group B will receive Parinata Keriksheeradi Taila Nasya, administered for 9 consecutive days, followed by a 27-day follow-up. Assessment will be based on subjective parameters such as pain and functional disability using validated scales, and objective parameters including shoulder joint range of motion measured by goniometry.
Statistical analysis will determine the comparative efficacy of both interventions. The study is expected to provide scientific evidence supporting the role of Nasya Karma in managing Avabahuka and offer a safer, effective Ayurvedic alternative for frozen shoulder management |