| CTRI Number |
CTRI/2023/11/059755 [Registered on: 13/11/2023] Trial Registered Prospectively |
| Last Modified On: |
09/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare efficacy of Nutri Leha as against Ready to Use Therapeutic Food in Karshya Severe Acute Malnutrition in children |
|
Scientific Title of Study
|
Assessment of comparative efficacy of Nutri Leha as against Ready to Use Therapeutic Food RUTF in management of Karshya Severe Acute Malnutrition in children Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Klita Maxim Pereira |
| Designation |
PG SCHOLAR |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9967902890 |
| Fax |
|
| Email |
klitapereira02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Klita Maxim Pereira |
| Designation |
PG SCHOLAR |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9967902890 |
| Fax |
|
| Email |
klitapereira02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renu Rathi |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9011058302 |
| Fax |
|
| Email |
renu.rathi@dmimsu.edu.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha |
| Address |
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha |
| 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 |
| Dr Klita Pereira |
Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha |
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha
Wardha
MAHARASHTRA |
09967902890
klitapereira02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E43||Unspecified severe protein-caloriemalnutrition. Ayurveda Condition: KARSYAM (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Nutri leha, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: dose will be calculated according to youngs formula as the age group is pediatric group from 6 months to 5 yrs | | 2 | Comparator Arm (Non Ayurveda) | | - | Ready to Use Therapeutic Food | dosage - 175 kcal/kg/day orally twice a day before food |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from karshya
Children having low weight for height below -3 SD low BMI for age and children falling in grade 3 and 4 classification of PEM according to IAP |
|
| ExclusionCriteria |
| Details |
Children having low weight for height below -3 SD low BMI for age and children falling in grade 1 and 2 classification of PEM according to IAP
Below 6 month and above 5 years
suffering from infectious diseases like TB HIV etc
Suffering from complicated severe acute malnutrition
Guardian who are not willing to give informed written consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Nutri Leha and Ready to Use Therapeutic Food in reducing clinical features of Karshya |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison & assessment of efficacy of Nutri Leha & Ready to Use Therapeutic Food on anthropometric values |
3 months |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The volunteers will be informed about the study protocol . Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to study approval will be taken From IEC,MGAHRC, Salod, Wardhaand CTRI registration will be done. After selection, each participant will be tested and selected according to the selection criteria. They are divided into two groups the trial is a two arm parallel group, randomized, open labelled, clinical standard controlled trial. It will include a 90 days treatment period with assessment on 15th , 30th, 45th, 60th, 75th, 90th day of treatment and follow up on 30th, 60th and 90th day post treatment. |