| CTRI Number |
CTRI/2019/02/017701 [Registered on: 18/02/2019] Trial Registered Prospectively |
| Last Modified On: |
14/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of dhanyakadi ghana vati in the patients having symptoms of grahani roga. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of dhanyakadi ghan vati with ushana jala & takra in the management of grahani roga. |
| 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 tripathi |
| Designation |
Professor of kayachikitsa department |
| Affiliation |
Rishikul campus uttarakhand ayurveda university haridwar uttarakhand |
| Address |
Rishikul campus uttarakhand Ayurveda university haridwar uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411503035 |
| Fax |
|
| Email |
Sanjaytripathi.230@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sanjay kumar tripathi |
| Designation |
Professor of kayachikitsa department |
| Affiliation |
Rishikul campus uttarakhand ayurveda university haridwar uttarakhand |
| Address |
Rishikul campus uttarakhand Ayurveda university haridwar uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411503035 |
| Fax |
|
| Email |
Sanjaytripathi.230@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sanjay kumar tripathi |
| Designation |
HOD of kayachikitsa department |
| Affiliation |
Rishikul campus uttarakhand ayurveda university haridwar uttarakhand |
| Address |
Rishikul campus uttarakhand Ayurveda university haridwar uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411503035 |
| Fax |
|
| Email |
Sanjaytripathi.230@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul campus UAU Haridwar |
|
|
Primary Sponsor
|
| Name |
Rishikul campus UAU Haridwar |
| Address |
Rishikul campus, U.A.U. Haridwar |
| 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 |
| Rashmi agari |
rishikul ayurvedic hospital, Haridwar. |
opd no-1,kayachikitsa
Hardwar
UTTARANCHAL |
7017794614
agarirashmi104@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E888||Other specified metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP-A |
20 patients will be treated with dhanyakadi ghan vati with anupan of takra 1TDS
in which each tablet are 500mg given oraly for 45 days and the assessment of the patients will be done 3 times at the interval of 15 days.and follow up will be done 1month after completion of treatment of 45 days. |
| Comparator Agent |
GROUP-B |
20patients will be treated with dhanyakadi ghan vati with anupan of ushana jala. in the dose of 1TDS in which each tablet are 500 mg given by oraly for the duration of 45 days,and assessment of the patients will be done 3 times at the interval of 15 days,and follow up will be done in 1 month after completion of treatment of 45 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients should fullfill both the subjective and objective criteria. |
|
| ExclusionCriteria |
| Details |
patients suffering from chronic illness or any systemic failure, and who have not fullfilling the sunjective or objective parameters. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of drugs,subjectively all sign and symptoms were given scoring depending upon their severity.
No sign-0
Mild-1
Moderate-2
severe-3
and objectively changes in stool like frequency,mucus,blood and ova cyst in stool. |
To assess the effect of drugs,subjectively all sign and symptoms were given scoring depending upon their severity.
No sign-0
Mild-1
Moderate-2
severe-3
and objectively changes in stool like frequency,mucus,blood and ova cyst in stool.for 45 days of study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Excerbation in sign and symptoms |
1 month |
|
|
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 1 |
|
Date of First Enrollment (India)
|
20/02/2019 |
| 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="4"
Days="15" |
|
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
|
Ttotal 40 patients of grahani roga will be selected from the opd and ipd of pg department of kayachikitsa uau,rishikul campus haridwar.the study will be conducted on the patients randomly devided into 2 groups that means 20 patients in each group on the basis of inclusion and exclusion criteria depending on the detailed clinical history ,physical examination and other necessary and desired investigation. The patients of grahani roga will be selected irrespective of Doshik predominance. |