| CTRI Number |
CTRI/2019/06/019491 [Registered on: 03/06/2019] Trial Registered Prospectively |
| Last Modified On: |
01/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Panchakarma treatment protocol in Anukta Vata Vyadhi |
|
Scientific Title of Study
|
Role of Panchakarma treatment protocol in Anukta Vata Vyadhi: Systemic review and an Upashaya based cross sectional observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/ACA/2018/2/6 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarvesh Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
National institute of Ayurveda Jaipur |
| Address |
Room no.2,Department of Panchakarma,National institute of Ayurveda,Jorawar Singh Gate, Jaipur,India
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarvesh Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
National institute of Ayurveda Jaipur |
| Address |
Room no.2,Department of Panchakarma,National institute of Ayurveda,Jorawar Singh Gate, Jaipur,India
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Sanjeev Sharma |
| Designation |
Director |
| Affiliation |
National institute of Ayurveda Jaipur |
| Address |
Director office,National institute of Ayurveda,Jorawar Singh Gate, Jaipur,India,
RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
8290996996 |
| Fax |
|
| Email |
profsanjeevhp@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of Ayurveda,Jorawar Singh Gate,Jaipur,Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute ofAyurvedaJaipur |
| Address |
National Institute ofAyurveda, Jorawar Singh Gate,Jaipur,Rajasthan |
| 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 |
| Dr Sarvesh Kumar Singh |
Madhav Vilas Hospital, National Institute of Ayurveda,Jaipur, |
Room no.2,Department of Panchakarma,National institute of Ayurveda,Jorawar Singh Gate, Jaipur,India
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
8739860237
sarveshksingh21@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: M958||Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients of Panchakarma department of NIA Hospital, Jaipur diagnosed with Anukta Vata Vyadhi.
2. Patients able to provide informed consent.
3. Patients above the Age of 18 – 70 years.
|
|
| ExclusionCriteria |
| Details |
1. Healthy volunteers
2. Patients unable to provide a written consent.
3. Patients unable to provide information in personal interview.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Treatment Satisfaction for Panchakarma Procedures |
one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life |
One month |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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 3 |
|
Date of First Enrollment (India)
|
10/06/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a systemic review and an Upshaya based cross sectional observational study.The main issue that will be addressed in this study is to determine the Upshaya for patients adopting Panchakarma treatment protocol in Anukta Vata Vyadhi.These will be assessed by quality of Life Questionnaire and treatment satisfaction questionnaire for medications after completion of one month of Panchakarma Procedures. |