| CTRI Number |
CTRI/2023/03/050963 [Registered on: 22/03/2023] Trial Registered Prospectively |
| Last Modified On: |
20/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of ashwagandha kshirapaka in underweight children
|
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of ashwagandha kshirapaka in karshya w s r to underweight children
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr palash vinod pande |
| Designation |
PG scholar |
| Affiliation |
yashwant ayurvedic college kodoli |
| Address |
OPD No 7 balrog opd yashwant charitable hospital kodoli tal panhala dist Kolhapur
OPD No 7 balrog opd yashwant charitable hospital kodoli tal panhala dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
07276824317 |
| Fax |
|
| Email |
palash.pande97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr pravatkumar dash |
| Designation |
Asso professor |
| Affiliation |
yashwant ayurvedic college kodoli |
| Address |
Second floor department of balrog yashwant charitable hospital kodoli tal panhala dist Kolhapur
Second floor department of balrog yashwant charitable hospital kodoli tal panhala dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277590 |
| Fax |
|
| Email |
drpkdash25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr palash vinod pande |
| Designation |
PG scholar |
| Affiliation |
yashwant ayurvedic college kodoli |
| Address |
OPD No 7 balrog opd yashwant charitable hospital kodoli tal panhala dist Kolhapur
OPD No 7 balrog opd yashwant charitable hospital kodoli tal panhala dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
07276824317 |
| Fax |
|
| Email |
palash.pande97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic college kodoli |
|
|
Primary Sponsor
|
| Name |
Dr palash vinod pande |
| Address |
OPD No 7 balrog opd yashwant charitable hospital kodoli tal panhala dist Kolhapur |
| Type of Sponsor |
Other [Self] |
|
|
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 Palash vinod pande |
Yashwant charitable hospital |
OPD No 7 balrog department ground floorcyashwant charitable hospital kodoli tal panhala dist Kolhapur
Kolhapur
MAHARASHTRA |
07276824317
palash.pande97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R636||Underweight. Ayurveda Condition: KARSYAM (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Granules , Reference: Kaidev nighantu , Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha kshirapaka , Reference: Kaidev nighantu , Route: Oral, Dosage Form: Ksheerpaka, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children between the age group of 2 - 10yrs.
Children from grade I( 71-80 %) and grade II ( 61- 70 %) Under-nutrition according to Indian Academy of Pediatrics classification.
Children on their regular diet. |
|
| ExclusionCriteria |
| Details |
Children in age group below 2 yrs and above 10 yrs
Children suffering from infectious and chronic systemic disorder.
Children of chromosomal, genetic, metabolic or congenital disorders.
The children of Grade III (51-60 % ) and IV (< 50 %) malnutrition will be excluded.
Patient unwilling to co-operate till the completion of intervention.
Any patient requiring hospitalization. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of AshwagandhaKshirapaka inKarshya (Underweight in children) |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study efficacy of ashwagandha granules in the karshya
2. To assess the efficacy of ashwagandhakshirapaka on the sign and symptom of karshya
3. To study Karshya in detail ayurvedic and modern view |
30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/04/2023 |
| 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="1"
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
|
This is randomized controlled clinical study to evaluate the efficacy of ashwagandha kshirapaka in karshya observation will be made upon symptoms of karshya study will be carried out in opd of balrog department of yashwant charitable hospital kodoli |