| CTRI Number |
CTRI/2021/09/036905 [Registered on: 28/09/2021] Trial Registered Prospectively |
| Last Modified On: |
24/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare Efficacy of Marichyadi churna and syrup Darvyadi in Tonsillitis(in children) |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Marichyadi churna and syrup Darvyadi in Tundikeri roga( Tonsillitis) in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Rakesh Sharma |
| Designation |
Professor HOD Department |
| Affiliation |
Rajiv Gandhi govt Post graduate ayurvedic college, paprola |
| Address |
Rajiv Gandhi government post graduate ayurvedic college and hospital paprola near KCC bank VPO Paprola teh baijnath district kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418105049 |
| Fax |
|
| Email |
hodkbpaprola8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rakesh Sharma |
| Designation |
Professor HOD Department |
| Affiliation |
Rajiv Gandhi govt Post graduate ayurvedic college, paprola |
| Address |
Rajiv Gandhi government post graduate ayurvedic college and hospital paprola near KCC bank VPO Paprola teh baijnath district kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418105049 |
| Fax |
|
| Email |
hodkbpaprola8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashi Jaiswal |
| Designation |
P. G scholar |
| Affiliation |
Rajiv Gandhi govt. Post graduate ayurvedic college, paprola |
| Address |
Rajiv Gandhi government post graduate ayurvedic college and hospital paprola near KCC bank VPO Paprola teh baijnath district kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9319751304 |
| Fax |
|
| Email |
jaiswalrashi13@gmail.com |
|
|
Source of Monetary or Material Support
|
| M/S Shashi Pal Gourav Kumar Karyana and merchants khoo bazar, paprola, district kangra HP |
|
|
Primary Sponsor
|
| Name |
Principal RGGPG Ayurvedic College and Hospital Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola Teh Baijnath Dist.Kangra HP |
| 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 |
| Prof Rakesh Sharma |
RGGPG AYURVEDIC COLLEGE AND HOSPITAL PAPROLA |
Room no 217,HOD DEPT BALROG, RGGPG AYURVEDIC COLLEGE AND HOSPITAL PAPROLA KANGRA
Kangra
HIMACHAL PRADESH |
9418105049
hodkbpaprola8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC (human) RGGPG AYURVEDIC COLLEGE AND HOSPITAL PAPROLA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B950||Streptococcus, group A, as the cause of diseases classified elsewhere. Ayurveda Condition: TUNDIKERI, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Marichyadi churna |
Marichyadi churna 80mg/kg/day for local application 2 times a day for 4weeks |
| Comparator Agent |
Syrup Darvyadi |
Syrup Darvyadi 0.5-1ml/kg/day in two divided doses for 4weeks |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.suffering from Tundikeri (tonsillitis). 2.who are willing to participate in the trial 3.whose parents will give their written informed consent |
|
| ExclusionCriteria |
| Details |
1.patients suffering from any congenital, hereditary or acute systemic illness 2.who do not fulfill the inclusion criteria 3.who have developed complications of tonsillitis 4.with unilateral tonsillar hypertrophy 5.patients of tonsillar lymphoma 6.who have dropped subsequent follow up 7.who have refused to participate in the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfilment of objective and subjective criteria;Objective criteria-Lab investigation, CBC, ESR, RFT, LFT..... Subjective criteria-relief in symptoms like pricking pain, sore throat, tonsillar hypertrophy, cough, foul breath, dysphagia, fever, discharge, lymhadenopathy, snoring |
At 2weeks and 4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General feeling of wellbeing |
4weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
01/10/2021 |
| 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="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I would like to publish my trial after completion of trial as soon as possible. Patients will be selected from campus facut/OPD of RGGPG AYURVEDIC COLLEGE AND HOSPITAL PAPROLA. 3 groups of 45 patients with 15 patients in each group will be selected based on inclusion and exclusion criteria to know the effect of Marichyadi churna and syrup Darvyadi in Tundikeri roga (tonsillitis) in children. |