| CTRI Number |
CTRI/2025/02/081082 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Koladi Avleha and Hyderabad Mix in Underweight Children. |
|
Scientific Title of Study
|
A clinical controlled trial on Koladi Avleha and Hyderabad Mix in the management of karshya in children |
| 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 Ritika Gupta |
| Designation |
MD scholar |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow |
| Address |
P.G.dept. of kaumarabhritya OPD NO.1 State Ayurvedic College and hospital, Lucknow
Lucknow
226003
UTTARPRADESH
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8765309176 |
| Fax |
|
| Email |
ritikagupta6297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Narayan Gupta |
| Designation |
Reader |
| Affiliation |
State Ayurvedic College and hospital, Lucknow |
| Address |
P.G.dept. of kaumarabhritya OPD NO.1 State Ayurvedic College and hospital, Lucknow
Lucknow
226003
UTTARPRADESH
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415447523 |
| Fax |
|
| Email |
mngupta75@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Narayan Gupta |
| Designation |
Reader |
| Affiliation |
State Ayurvedic College and hospital, Lucknow |
| Address |
P.G.dept. of kaumarabhritya OPD NO.1 State Ayurvedic College and hospital, Lucknow
Lucknow
226003
UTTARPRADESH
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415447523 |
| Fax |
|
| Email |
mngupta75@yahoo.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital,Turiyaganj,Tulsidas Marg,Lucknow,Uttar pradesh
Pincode 226003 |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Lucknow |
| Address |
Tulsidas Marg,Turiyaganj old Haiderganj, Lucknow
Pincode- 226003
Uttarpradesh
India |
| 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 |
| Dr Ritika Gupta |
State Ayurvedic College and Hospital , Lucknow |
P.G. Dept. Of kaumarabhritya OPD NO. 1 State Ayurvedic College and Hospital,Tulsidas Marg,Turiyaganj,Lucknow,Uttar Pradesh
Pincode- 226003
Lucknow
UTTAR PRADESH |
8765309176
ritikagupta6297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Ethics Committee State Ayurvedic College and Hospital Lucknow Tulsidas Marg,Turiyaganj pincode - 226003 Uttarpradesh |
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: KARSYAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Koladi Avleha , Reference: Astanga sanghraha uttarsthana 2/47, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Hyderabad Mix | Wheat- 40gm
Bengal gram- 16gm
Ground nut- 10gm
Jaggery- 20gm |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1-Patients having age between 6 year to 10
years.
2-Both male and females sex are included.
3-Patients lying under diagnostic criteria.
4-Essential inclusion criteria a/c to IAP
Grading.
5-Only mild and moderate malnutriton cases are
included.
|
|
| ExclusionCriteria |
| Details |
1-Severe and very severe malnourished child.
2-Children with cardiac disease, renal, hepatic,endocrinal disease.
3-Children having to pneumonia,tuberculosis infection.
4-Children with any systemic disorder which interfere with the present treatment.
5-Children with any congenital anomalies and genetic disorders.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in malnourished child |
After 90 days of complete clinical trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Weight of
Malnourished child. |
3 Months |
|
|
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 2 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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="3"
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
|
A malnourished child experiences impaired growth and development therefore I select this trial, this research evaluate the efficacy of koladi Avleha and Hyderabad Mix. This research is open Label parallel group randomized clinical study. Maximum 40 subject will be taken aged between 6 to 10 years. In first group koladi Avleha will be given orally in two divided dose and in second group Hyderabad Mix will be given orally as per nutritional requirement . The total duration of trial is 3 month and follow up will be done at interval of 15 days of 3 month and a final follow-up will be done at interval of 15 days of 1 month. |