| CTRI Number |
CTRI/2021/08/035623 [Registered on: 12/08/2021] Trial Registered Prospectively |
| Last Modified On: |
14/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Malnutrition in children |
|
Scientific Title of Study
|
A COMPARATIVE PHARMACEUTICO-ANALYTICAL AND CLINICAL STUDY ON TILADI CHURNA AND ITS GRANULES ALONG WITH ITS EFFECT ON MALNUTRITION 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 |
Vani Gayathri PA |
| Designation |
MD scholar |
| Affiliation |
Dr.Sarveppalli Radhakrishnan Rajasthan Ayurved University |
| Address |
PG Department of Rasa Shastra and Bhaishajya Kalpana
Dr.Sarveppalli Radhakrishnan Rajasthan Ayurved University
Nagaur Road
Kadwad
Jodhpur
Rajasthan
PG Department of Rasa Shastra and Bhaishajya Kalpana
Dr.Sarveppalli Radhakrishnan Rajasthan Ayurved University
Nagaur Road
Kadwad
Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9746453356 |
| Fax |
|
| Email |
vanigayathripa1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Goyal |
| Designation |
Assosciate Professor |
| Affiliation |
Dr.Sarveppalli Radhakrishnan Rajasthan Ayurved University |
| Address |
PG Department of Rasa Shastra and Bhaishajya Kalpana
Dr.Sarveppalli Radhakrishnan Rajasthan Ayurved University
Nagaur Road
Kadwad
Jodhpur
Rajasthan
PG Department of Rasa Shastra and Bhaishajya Kalpana
Dr.Sarveppalli Radhakrishnan Rajasthan Ayurved University
Nagaur Road
Kadwad
Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8890242078 |
| Fax |
|
| Email |
manishagoyal29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vani Gayathri PA |
| Designation |
MD scholar |
| Affiliation |
Dr.Sarveppalli Radhakrishnan Rajasthan Ayurved University |
| Address |
PG Department of Rasa Shastra and Bhaishajya Kalpana
Dr.Sarveppalli Radhakrishnan Rajasthan Ayurved University
Nagaur Road
Kadwad
Jodhpur
Rajasthan
PG Department of Rasa Shastra and Bhaishajya Kalpana
Dr.Sarveppalli Radhakrishnan Rajasthan Ayurved University
Nagaur Road
Kadwad
Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9746453356 |
| Fax |
|
| Email |
vanigayathripa1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| DrSarveppalli Radhakrishnan Rajasthan Ayurved University |
|
|
Primary Sponsor
|
| Name |
DrSarveppalli Radhakrishnan Rajasthan Ayurved University |
| Address |
Dr.Sarveppalli Radhakrishnan Rajasthan Ayurved University
Nagaur Road
Kadwad
Jodhpur
Rajasthan
342037 |
| 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 |
| DrManisha Goyal |
Dr.Sarveppalii Radhakrishnan Rajasthan Ayurveda University |
OPD no.6
PG Department of Kaumarabhritya
Dr.Sarveppalli Radhakrishnan Rajasthan Ayurved University
Nagaur Road
Kadwad
Jodhpur
Rajasthan
342037
Jodhpur
RAJASTHAN |
8890242078
manishagoyal29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E46||Unspecified protein-calorie malnutrition. Ayurveda Condition: BALAROGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tiladi Churn granules |
Tiladi Churn granules will be given in the dose of 50 gram(1 Pala)which will be given as 2 divided doses with the anupan of milk for 2 months. |
| Intervention |
Tiladi Churna |
Tiladi Churna in the dose of 12 gram(1 Karsh)which will be given as two divided doses with the Anupan of milk for 2 months |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Children are of age group 5-10 yearsof both sexes.
2.Grade 1&2 undernourished children satisfying IAP Classification. |
|
| ExclusionCriteria |
| Details |
1.Children of age below 5 and above 10
2.Malnutrition grade 3&4
3.Patient having any systemic diseases
4.Patient having congenital disease, in error of metabolism, celiac disease etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Anthropometric assessment
|
Baseline and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Investigation criteria
1.CBC
2.ESR
3.Serum Protein
4.Serum Albumin
5.A/G ratio |
Baseline and 8 weeks |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/08/2021 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
Malnutrition becomes one of the most common causes of morbidity and mortality among the children.This study is randomised parallel group trial to find out the efficacy of Tiladi Churna a herbal formulation mentioned in Gadanigraha In first group 15 well diagnosed and registered patients will be given Tiladi churna in the dose of 12 gram as two divided doses with anupan of milk for 2 months.In second group, 15 well diagnosed and registered patients will be given Tiladi Churna granules in the dose of 50 grams as 2 divided doses with the anupan of milk for 2 months. |