| CTRI Number |
CTRI/2019/01/016963 [Registered on: 08/01/2019] Trial Registered Prospectively |
| Last Modified On: |
01/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
AYURVEDIC MANAGEMENT OF CERVICAL SPONDYLOSIS |
|
Scientific Title of Study
|
EFFICACY OF VAJIGANDHADI YOGA AND SVALPAMASHA TAILA NASYA IN THE MANAGEMENT OF CERVICAL SPONDYLOSIS W.S.R. TO MANYASTAMBHA: AN OPEN LABELLED RANDOMIZED COMPARATIVE CLINICAL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Appurva Sharma |
| Designation |
MD AYU Scholar Department of Kayachikitsa |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
IPGT and RA GUJARAT AYURVED UNIVERSITY Near GGH hospital Jamnagar
4th floor Department of Kayachikitsa New building IPGT and RA GUJARAT AYURVED UNIVERSITY Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9780914411 |
| Fax |
|
| Email |
appurva.appu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alankruta R Dave |
| Designation |
Associate Professor Department of Kayachikitsa |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
4th floor Department of Kayachikitsa New building IPGT and RA GUJARAT AYURVED UNIVERSITY Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9824171817 |
| Fax |
|
| Email |
alankruta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
APPURVA SHARMA |
| Designation |
MD AYU Scholar Department of Kayachikitsa |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Department of Kayachikitsa New building IPGT and RA GUJARAT AYURVED UNIVERSITY Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9780914411 |
| Fax |
|
| Email |
appurva.appu@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGT and RA GUJARAT AYURVED UNIVERSITY Jamnagar GUJRAT 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
| Address |
IPGT and RA GUJARAT AYURVED UNIVERSITY Near GGH Hospital Jamnagar 361008 |
| 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 |
| Appurva Sharma |
Institute for Post Graduate Teaching and Research in Ayurveda |
Department of kayachikitsa, Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT |
9780914411
appurva.appu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Group A- Vajigandhadi Yoga two tab(500mg) thrice a day after meals |
| Comparator Agent |
Group B |
Group B- Nasya with Svalpmasha tail 4ml each nostril once a day + Vajigandhadi Yoga 2tab(500mg) thrice a day after meals |
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
1 Patients having signs and symptoms of Cervical Spondylosis
2 X-ray of cervical spine showing relevant changes of Cervical Spondylosis like narrowing of joint space and osteophytes at the vertebral margins
3 Patient between age of 20-65 of either sex and willing to give their consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1 patients below the age of 20 and above 65
2 Patient having associated conditions like fibrositis, rheumatoid spondylitis, ankylosing spondylitis
3 Pregnancy, Lactation
4 TB of cervical spine
5 Nasal polyps
6 Active Malignant disease.
7 Uncontrolled Diabetes Mellitus, Uncontrolled Hypertension
8 Pakshaghat, Avbahuka, Khanja
9 Complication of Cervical spondylosis (like paraplegia, bladder and bowel involvement)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| management of pain and improvement in other sign and symptom of cervical spondylosis |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improve quality of life of patients of cervical spondylosis |
8 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/01/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is the randomized clinical trial to evaluate the effect of Vajigandhadi Yoga and Svalpmasha tail nasya in the managment of Cervical Spondylosis(Manyastambha). Total 30 patient will be enrolled in present study. Selected patient will be divided in two groups on the basis of computer generated randomisation method. In this study Group A will be given Vajigandhadi Yoga in dose of 2 tablet(500mg each) TDS after meals with normal water for 8 weeks. In Group B same dose of Vjigandhadi yoga will be administer along with 3 sitting Svalpmasha tail in the dose of 4ml each nostril at morning once in a day for 7 days with the interval of 7 days. Follow up will be carried out at every week for the interval of one month. |