| CTRI Number |
CTRI/2019/09/021091 [Registered on: 06/09/2019] Trial Registered Prospectively |
| Last Modified On: |
05/09/2019 |
| 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
|
A CLINICAL STUDY OF NASYA KARMA WITH HRASHVA PANCH-MOOL TAIL AND ABHYANGA WITH KUKUTAND YOGA IN THE MANAGEMENT OG MANYASTAMBHA W.S.R TO CERVICAL SPONDYLOSIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepika Nagar |
| Designation |
MD ayu panchakarma |
| Affiliation |
DrSarvepalli Radhakrishnan Rajasthan ayurved University College ofJodhpur |
| Address |
DrSarvepalli Radhakrishnan Rajasthan ayurved University College ofJodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9461202980 |
| Fax |
|
| Email |
deepsnagar31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Assistant professor |
| Affiliation |
DrSarvepalli Radhakrishnan Rajasthan ayurved University College ofJodhpur |
| Address |
DrSarvepalli Radhakrishnan Rajasthan ayurved University College ofJodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika Nagar |
| Designation |
MD ayu |
| Affiliation |
DrSarvepalli Radhakrishnan Rajasthan ayurved University College ofJodhpur |
| Address |
DrSarvepalli Radhakrishnan Rajasthan ayurved University College ofJodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9461202980 |
| Fax |
|
| Email |
deepsnagar31@gmail.com |
|
|
Source of Monetary or Material Support
|
| DrSarvepalli Radhakrishnan Rajasthan ayurved University College ofJodhpur |
|
|
Primary Sponsor
|
| Name |
DrSarvepalli Radhakrishnan Rajasthan ayurved University College ofJodhpur |
| Address |
DrSarvepalli Radhakrishnan Rajasthan ayurved University College ofJodhpur pg department of panchakarma opd no 6 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrGyan Prakash Sharma |
University hospital of Ayurved Karwar Jodhpur |
PG department of panchakarma Dr sarvepalli Radhakrishnan Rajasthan ayurved University College of Jodhpur Karwar
Jodhpur
RAJASTHAN |
9829798701
atreyagyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional ethical committee Dr sarvepalli Radhakrishnan Rajasthan ayurved University College of Jodhpur |
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 |
| Comparator Agent |
Abhyanga with kukuttand yoga |
Abhyanga with kukuttand yoga for 14days |
| Intervention |
Nasya Karma with Harshv-panchmool tail |
Nasya Karma on daily with dose of 6drop each nostril for 14days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from classical sign and symptom of Manya-stambh cervical spondylosis. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women.
2.Stenosis of spinal canal.
3.Patient with major systemic disease that may interfere with the of treatment.
4. Patient suffering from any acute disease /infectious disease/ metabolic disease /chronic disease like rheumatoid arthritis ,ankylosing spondylitis ,DM, gout, TB ,SLE etc |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improve in signs and symptoms of Manya-stambh (cervical spondylosis) |
Improve in signs and symptoms of Manya-stambh (cervical spondylosis) 4week after |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of Manya-stambh (cervical spondylosis) |
Follow up will be done for 30days and after completion of treatment |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
12/09/2019 |
| 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="1"
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 evaluate the effect of Harshv-panchmool tail Nasya and Abhanga with kukuttand yoga in the management of Manya-stambha(cervical spondylosis). Total 30 patients Will be enrolled in present study. Selected patient will be divided in three groups on the basis of randomization method in this study group A will be given nasya with Harshv-panchmool tail for 14 days.In group B will be given Abhanga with kukuttand yoga for 14days . Follow up will be carried out at every week for interval of 1 month |