| CTRI Number |
CTRI/2026/03/105917 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Ayurvedic Nasal Oil Treatment and Ultrasound Therapy for Radiating Arm Pain |
|
Scientific Title of Study
|
An Open-Labelled Randomised Comparative Clinical Study of Mahamasha Taila Nasya and Ultrasound Therapy in Vishwachi |
| 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 Shreeraksha Ramesh Rao |
| Designation |
Post Graduate Resident |
| Affiliation |
Muniyal Institute of Ayurveda Medical Sciences |
| Address |
Out Patient Ward Department of Panchakarma Ground Floor Room No. 3 Muniyal Institute of Ayurveda Medical Sciences 34-C Shivalli Industrial Area Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8792831578 |
| Fax |
|
| Email |
rakshabattaje@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sudarshan A |
| Designation |
Professor |
| Affiliation |
Muniyal Institute of Ayurveda Medical Sciences |
| Address |
Out Patient Ward Department of Panchakarma Ground Floor, Room No. 3 Muniyal Institute of Ayurveda Medical Sciences 34-C Shivalli Industrial Area Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9481227666 |
| Fax |
|
| Email |
drsalevoor@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shreeraksha Ramesh Rao |
| Designation |
Post Graduate Resident |
| Affiliation |
Muniyal Institute of Ayurveda Medical Sciences |
| Address |
Out Patient Ward Department of Panchakarma Ground Floor Room No. 3 Muniyal Institute of Ayurveda Medical Sciences 34-C Shivalli Industrial Area Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8792831578 |
| Fax |
|
| Email |
rakshabattaje@gmail.com |
|
|
Source of Monetary or Material Support
|
| Muniyal Institute of Ayurveda Medical Sciences
34-C Shivalli Industrial Area
Manipal Udupi
KARNATAKA
576104
India |
|
|
Primary Sponsor
|
| Name |
Muniyal Institute of Ayurveda Medical Sciences |
| Address |
34-C Shivalli Industrial Area Manipal Udupi
KARNATAKA
576104
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 Shreeraksha Ramesh Rao |
Muniyal Institute of Ayurveda Medical Sciences |
Out Patient Ward
Department of Panchakarma
Ground Floor Room No. 3
Muniyal Institute of Ayurveda Medical Sciences
34-C Shivalli Industrial Area Manipal Udupi KARNATAKA |
8792831578
rakshabattaje@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muniyal Institute of Ayurveda Medical Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nAvanam, नावनम् | (Procedure Reference: Chakradatta, Procedure details: Medicinal drug will be administered in empty stomach condition for 7 days.) (1) Medicine Name: Mahamasha Taila, Reference: Sahasrayogam, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Ultrasound Therapy | Ultrasound therapy will be administered to affected area once daily for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants with classical symptoms of Vishwachi.
Participants of the age group between 21-60 years.
Participants who are fit for Nasya or ultrasound therapy
|
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating mother.
Any acute traumatic or infectious conditions.
Participants with congenital deformities of spine.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in reduction of pain and functional impairment when comparing the Mahamasha Taila Nasya group against the Ultrasound Therapy group at the end of the treatment period. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The pre-and-post-treatment change in clinical signs of Vishwachi within each group |
7 days 14 days |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="1" Months="4" 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
|
In the present era sedentary lifestyle and prolonged usage of computer screens has increased the risk of conditions like cervical and lumbar spondylosis. Vishwachi is a common condition with signs and symptom of Karmakshaya of Bahu due to the affliction of Kandara of Hastatala, Bahuprishtha and Anguli. In contemporary science it can be correlated to cervical spondylosis, a degenerative condition of the cervical spine. Our Acharyas opine that in Urdhwa Jatrugata Rogas, Nasya’ is highly effective, convenient, time and cost effective. Here in this study Nasya with Mahamasha Taila is taken. This formulation has been explained in Sahasrayogam and indicated in many Vatavyadhis including Vishwachi. Physiotherapy modalities can be used to reduce pain and stiffness in cervical spondylosis. Ultrasound therapy has been widely used in tissue healing. The application of ultrasound to injured tissues will speed up the rate of healing and enhance the quality of repair. Many papers have concentrated on the thermal effectiveness of ultrasound and how it can effectively be used in an appropriate dose. Keeping in view of all the above references and increasing incidence a comparative clinical study to evaluate the efficacy of Nasya with Mahamasha Taila and ultrasound therapy in management of Vishwachi has been taken up.
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