| CTRI Number |
CTRI/2024/12/077725 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to Compare the effect of Yavani Panchakam Yog and Haritaki Sunthi Yog in the management of Agnimandya (Loss of Appetite) in Children. |
|
Scientific Title of Study
|
A Randomized Open Labelled Comparative Controlled Clinical Study to evaluate the efficacy of Yavani Panchakam Yog and Haritaki Sunthi Yog in the management of Agnimandya (Loss of Appetite) 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 Purnima |
| Designation |
PG SCHOLAR |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
9588748858 |
| Fax |
|
| Email |
purnimaaggarwal795@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Vd S D Sharma |
| Designation |
Chairperson PG Dept. of Kaumarbhritya |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7988688231 |
| Fax |
|
| Email |
sharmasddr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purnima |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9588748858 |
| Fax |
|
| Email |
purnimaaggarwal795@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118
|
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies And Research |
| Address |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118
|
| 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 Purnima |
Institute For Ayurved Studies And Research Hospital |
Room no 100
PG Department of
Kaumarbhritya Institute
for Ayurved Studies and
Research Umri Road
Sector 8 Kurukshetra
Kurukshetra
HARYANA |
9588748858
purnimaaggarwal795@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University IEC |
Approved |
| SKAU KURUKSHETRA IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ANNAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yavani Panchak yog, Reference: Bhaishajya ratanvali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -this yog is taken from bhesaj ratanvali and no previous research has been done on this | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritaki Sunthi Yog, Reference: Bhaishajya Ratanvali 10/10, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children whose parents have willing to participate in the research trial.
The patients having signs and symptoms of Agnimandya mentioned in Ayurvedic Samhitas.
Patients between the age group 4 to 12 years will be selected irrespective of sex, religion
and socioeconomic status.
History of reduced food intake.
|
|
| ExclusionCriteria |
| Details |
Patients in the age below 4 year and above 12 years.
Patients having acute infection.
Known case of moderate to severe anemia, malnutrition, jaundice, tuberculosis, stress |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
It will be assessed on the basis of statistical analysis applied on subjective parameters after
completion of trial. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Literary data related to Agnimandya (Loss of appetite) will be complied from different texts
of Ayurveda and modern part.
Effect of Pathya- Apathya will be assessed in the patients of Agnimandya. |
7th day 14th day 21 day 28th day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2024 |
| 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
Modification(s)
|
Years="2"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 Randomized Open Labelled Comparative Controlled Clinical Study to evaluate the efficacy of Yavani Panchakam Yog and Haritaki Shunthi Yog in the Management of Agnimandya (Loss of Appetite) in Children of Age group 4 to 12 year of Age .The present study is comparative, also the yog selected for present study is taken from Bal Rog Prakrana. Childern younger than 4 yr is not included in the present study as they have physiologically weak digestive fire.Agnimandya is the root cause of all diseases. There is no survival possible without Agni as Shanto Agni Mriyate. Treatment of Agni Should be the prime goal of physician. The goal of the present study is to cure Agnimandya which can help childen in their growth and development. |