| CTRI Number |
CTRI/2025/01/078874 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to test the effect of Shiradi Ghrita(Ayrvedic Formulation) and Hyderabad mix on Malnourished children aged 1 to 6 years. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study To Evaluate The Effect Of Sthiradi Ghrita And Hyderabad Mix On Karshya In Children Of Age 1-6 Years |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Vijayprakash Chaubey |
| Designation |
PhD Student |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
d 101 binawat township, kalepadal road, sasane nagar, hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
7276587362 |
| Fax |
|
| Email |
pooja.chaubey070@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr . Vikas B. Jaybhay |
| Designation |
Professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Department of Kaumarbhritya, Tilak Ayurved Mahavidyalay, Rastapeth, pune
Pune
MAHARASHTRA
411011
India |
| Phone |
7276587362 |
| Fax |
|
| Email |
vikasjaybhay110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Vijayprakash Chaubey |
| Designation |
PhD Student |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
d 101 binawat township, kalepadal road, sasane nagar, hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
7276587362 |
| Fax |
|
| Email |
pooja.chaubey070@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarbhritya, tilak ayurvd college, jagtap road, rasta peth pune, maharshtra, pin code- 411011 |
| Department of Kaumarbhrutya,Dr M.N. Agashe Charitable Hospital satara Affiliated To Seth Chandanmal Mutha Aryngla Vaidyak Mahavidyalaya, Satara, pin code 415002 |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Vijayprakash chaubey |
| Address |
seth tarachand ramnath charitable hospital, rasta peth, Pune Maharashtra, pin code 411011 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja vijayprakash chaubey |
Seth chandanmal mutha aryngla vaidyak mahavidyalaya |
satara
Satara
MAHARASHTRA |
07276587362
pooja.chaubey070@gmail.com |
| Dr Pooja vijayprakash chaubey |
Seth tarachand ramnath charitable hospital , rasta peth |
Rasta Peth, Pune
Pune
MAHARASHTRA |
7276587362
pooja.chaubey070@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Seth Chandanmal Mutha Aryngla Vaidyak Mahavidyalaya |
Approved |
| Tilak Ayurved Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E440||Moderate protein-calorie malnutrition. Ayurveda Condition: KARSHNYAM (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sthiradi Ghrita, Reference: Ashtang Sangraha Uttarsthan 2/48, Route: Oral, Dosage Form: Ghrita, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: with initial 5 morsels of meals), Additional Information: Dose- 4ml to 12 ml according to age of child in two divided dosage | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shtiradi Ghrita and Hyderabad mix, Reference: Ashtang Sangraha and National institute of nutrition hyderabad, Route: Oral, Dosage Form: Ghrita, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: with initial 5 morsels of meals), Additional Information: Dosage is 4 ml to 12 ml according to age of child in two divided dosage | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Hyderabad Mix, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: dosage is 4ml to 12 ml according to age of child in two divided dosage
Reference of Hyderabad mix - National institute of nutrition Hyderabad |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
- Children in the age group 1-6 years irrespective of sex, and religion.
- Children with gade 1 and 2 i.e, with mild and moderate malnutrition accorging |
|
| ExclusionCriteria |
| Details |
- Severely malnourished children- grade 3 and 4 according to IAP classification.
- Children with active systemic or surgical illness.
- Children with chromosomal, congenital, metabolic or genetic disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sthiradi Ghrita more effective than Hyderabad mix in management of Karshya in children of age group 1-6 years. |
45days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sthiradi Ghrita with Hyderabad mix has an add on effect than Hyderabad mix alone in management of Karshya in children of Age 1-6 years |
45days |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
12/02/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In India 35.3% of total population falls under the pediatric age group. They are prone to various health problems and considered as special risk group. Among the various diseases they suffer the underlying cause most of the times is Undernutrition. This study is Randomized clinical controlled trial. Primary objective of this study is to evaluate the effect of Sthiradi Ghrita over Hyderabad mix in management of Karshya( undernutrition) in children of age 1-6 years. Secondary objectives of this study are to compare the effect of Sthiradi Ghrita with Hyderabad mix in Karshya, to study add on effect of Shtiradi Ghrita with Hyderabad mix against Hyderabad mix alone in Karshya and to study adverse effects of Sthiradi Ghrita if any. This study is divided in 3 groups. group A - Sthiradi Ghrita per oral twice a day for 45 days with Hyderabad mis as per energy requirement and dietary advice. Group B - Sthiradi Ghrita per oral twice a day day along with dietary advice. Group C - Hyderabad mix as per energy requirement for 45 days along with dietary advice. follw up on day 7th, 15th, 30th and 45th day of treatment and after completion on 75th day will be taken. sample size - considering a drop out of 30% minimum 250 patients will be enrolled in the study. this study is aimed at completing 75 pstients in each group. |