| CTRI Number |
CTRI/2022/07/044195 [Registered on: 21/07/2022] Trial Registered Prospectively |
| Last Modified On: |
20/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Dashmoola Kwatha in the management of Vatika Shotha(Oedema) |
|
Scientific Title of Study
|
Etiopathological Study of Vatika Shotha and its Samprapti Vighatan with Dashmoola kwatha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Kumar Singh |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, UAU, Haridwar |
| Address |
OPD No.21 & IPD Department of Roga Nidan, Rishikul Campus Uttarakhand Ayurved University,Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7060754892 |
| Fax |
|
| Email |
drsanjaysingh1970@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kumar Singh |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, UAU, Haridwar |
| Address |
OPD No.21 & IPD Department of Roga Nidan, Rishikul Campus Uttarakhand Ayurved University,Haridwar
UTTARANCHAL
249401
India |
| Phone |
7060754892 |
| Fax |
|
| Email |
drsanjaysingh1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Km Deepika Bhatt |
| Designation |
P.G.Scholar |
| Affiliation |
Rishikul Campus, UAU, Haridwar |
| Address |
OPD No.21 & IPD Department of Roga Nidan, Rishikul Campus Uttarakhand Ayurved University,Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9084725063 |
| Fax |
|
| Email |
kmdeepika091@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No. 21 & IPD Department of
Roga Nidan, Rishikul Campus, UAU, Haridwar |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University,Harrawala Dehradun |
| 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 |
| Km Deepika Bhatt |
Rishikul Campus UAU Haridwar |
OPD No.21 & IPD Department of Roga Nidan Rishikul Campus Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL |
9084725063
kmdeepika091@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comitte |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I999||Unspecified disorder of circulatory system. Ayurveda Condition: SARVASARA-SOTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashmoola Kwatha, Reference: Bhavaprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical symptoms of Vatika Shotha.
|
|
| ExclusionCriteria |
| Details |
Patients having Vatika Shotha due to Agantuja (trauma or injury) and Visaja (allergic or drug reaction) cause are excluded.
Patient suffering from life threatening chronic disorders such as renal disorders, chronic liver diseases,malignancy, diabetes melltius and other endocrinal disorders.
Patients on diuretics.
Pregnancy induced oedema.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of factors respomsible for the pathogenesis of Vatika shotha.
|
45 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Dashmool kwatha in Vatika Shotha.
|
45 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/07/2022 |
| 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 Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
Shotha (oedema) is a very common manifestation perhaps every individual comes across once or more in their lifetime. According to Samprapti given by different Acharyas Shotha is a Tridosaja vyadhi but predominantly vata is involved. In present study "Dashmool kwatha" will be given as Upshayatmak Chikitsa for samprapti Vighatan of Shotha as mentioned by Acharya "Chakrapani’’ in Vatika Shotha as Vathar & Shothhar (ubhaya-vipreet) under 18 types of upshaya.This study provide important information about disease trends, risk factors, and outcome of therapeutic effect of Dashmool kwatha. Through this clinical trial efficacy and adverse effects of Dashmoola kwatha in patients of Vatika Shotha can be assessed. |