| CTRI Number |
CTRI/2023/10/059210 [Registered on: 27/10/2023] Trial Registered Prospectively |
| Last Modified On: |
23/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Gandha Taila Nasya (medicine administered through nasal route) in the management of Vishwachi (cervical spondylosis) and comparing its effect with Tila Taila Nasya (medicine administered through nasal route) |
|
Scientific Title of Study
|
“RANDOMIZED DOUBLE BLIND CONTROLLED CLINICAL STUDY
ON GANDHA TAILA NASYA IN THE MANAGEMENT OF 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 MAMATHA |
| Designation |
PG SCHOLAR |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
ALVAS AYURVEDA MEDICAL COLLEGE
VIDYAGIRI,MOODBIDIRE D K DISTRICT KARNNATAKA, INDIA
PG SCHOLAR DEPARTMENT OF PG STUDIES IN
PANCHAKARMA
Dakshina Kannada
KARNATAKA
574227
ALVAS AYURVEDA MEDICAL COLLEGE
VIDYAGIRI,MOODBIDIRE D K DISTRICT KARNNATAKA, INDIA
Dakshina Kannada
KARNATAKA
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9663888725 |
| Fax |
|
| Email |
mamatharshettigar06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIKRAM KUMAR |
| Designation |
PROFESSOR , GUIDE |
| Affiliation |
LVAS AYURVEDA MEDICAL COLLEGE |
| Address |
Alvas Ayurveda Medical College Vidyagiri,Moodbidre Dakshina
Kannada District Karnnataka, India Professor, Guide Department of
Pg Studies in Panchakarma
Dakshina Kannada
KARNATAKA
574227
ALVAS AYURVEDA MEDICAL COLLEGE
VIDYAGIRI,MOODBIDIRE D K DISTRICT KARNNATAKA, INDIA
Dakshina Kannada
KARNATAKA
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9483141326 |
| Fax |
|
| Email |
vikramkumar83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MAMATHA |
| Designation |
PG SCHOLAR |
| Affiliation |
LVAS AYURVEDA MEDICAL COLLEGE |
| Address |
Alvas Ayurveda Medical College Vidyagiri,Moodbidre Dakshina
Kannada District Karnnataka, India
PG scholar
Department of PG Studies in Panchakarma
Dakshina Kannada
KARNATAKA
574227
ALVAS AYURVEDA MEDICAL COLLEGE
VIDYAGIRI,MOODBIDIRE D K DISTRICT KARNNATAKA, INDIA
Dakshina Kannada
KARNATAKA
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9663888725 |
| Fax |
|
| Email |
mamatharshettigar06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Alvas Ayurveda Medical College and Hospital Vidyagiri
Moodbidri |
|
|
Primary Sponsor
|
| Name |
Dr MAMATHA |
| Address |
PG Scholar Department Of PG Studies In Panchakarma Alvas
Ayurveda Medical College,Vidyagiri Moodbidre Dakshina Kannada
District,Karnnataka |
| 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 MAMATHA |
Alvas Ayurveda Medical college and Hospital Moodbidri |
Panchakarma OPD of Alvas Ayurveda
Medical college and
Hospital Vidhyagiri,
moodbidri
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
9663888725
mamatharshettigar06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee Alvas Ayurveda Medical College Vidyagiri Moodbidri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: VISVACI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: MOORCHITA TILA TAILA, Reference: BHAISHAJYA RATHNAVALI JWARADHIKARA 5TH CHAPTER 1286-1287 SHLOKA, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: GANDHA TAILA, Reference: ASTANGA HRIDAYA UTTARA STANA 27TH CHAPTER 36-41 SHLOKA, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
pain radiating from upper limb to fingers
Associated with any of the following symptoms
1. weakness
2. stiffness
3. tingling sensation
4. Pain in cervical region
5. Positive Spurling test
patients who are fit for nasal drug administration |
|
| ExclusionCriteria |
| Details |
1. Congenital condition of cervical spine.
2. Patients with the history of trauma of cervical spine.
3. Contraindicated for nasal drug administration |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in
1. Neck pain
2. Neck stiffness
3. Tingling sensation
4. Neck disability index |
7th, 15th and 30th day after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
changes in range of motion in neck in terms of
1. Flexion
2. Extension
3. Lateral rotation
4. Right lateral flexion
5. Left lateral flexion |
7th, 15th and 30th day after treatment |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2023 |
| 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
|
It is a comparartive clinical study to evaluate the efficacy of Gandha Taila Nasya in Vishwachi in comparision to proven Moorchita Tila Taila Nasya. 20 patients will be taken in each group and treatment of Nasya Karma will be given for 7days with dosage of 4ml in each nostril. The study will be conducted in Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodbidri. Observation of parameters will be done on 7th, 15th and 30th day after treatment. |