| CTRI Number |
CTRI/2023/07/054916 [Registered on: 06/07/2023] Trial Registered Prospectively |
| Last Modified On: |
06/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study Between Yashtimadhu Ghrita And Ashwagandha Ghrita In Karshya w.s.r To Underweight In Children |
|
Scientific Title of Study
|
A Comparitive Clinical Study To Assess The Effect Of Yashtimadhusadhit Ghrita and Ashwagandha Ghrita in Karshya w.s.r to Underweight 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 Ashwarya Gaur |
| Designation |
PG Scholar, Kaumarbhritya |
| Affiliation |
Dr D.Y. Patil University ,School Of Ayurveda |
| Address |
1st Floor, OPD no.- 7, Department of Kaumarbhritya, Block no. 10, Dr.D.Y. Patil University, School of Ayurveda, Sector-7, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9149153119 |
| Fax |
|
| Email |
gaurashwarya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Dhuri |
| Designation |
HOD, Department Of Kaumarbhritya |
| Affiliation |
Dr D.Y. Patil University, School Of Ayurveda |
| Address |
1st Floor, OPD no.- 7, Department of Kaumarbhritya, Block no. 10, Dr.D.Y. Patil University, School of Ayurveda, Sector-7, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9321835616 |
| Fax |
|
| Email |
dhurikalpana34@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Dhuri |
| Designation |
HOD, Department Of Kaumarbhritya |
| Affiliation |
Dr D.Y. Patil University, School Of Ayurveda |
| Address |
1st Floor, OPD no.- 7, Department of Kaumarbhritya, Block no. 10, Dr.D.Y. Patil University, School of Ayurveda, Sector-7, Nerul, Navi Mumbai
MAHARASHTRA
400706
India |
| Phone |
9321835616 |
| Fax |
|
| Email |
dhurikalpana34@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.Y Patil School Of Ayurveda, D.Y. Patil University, Sector-7, Nerul, Navi Mumbai, 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Ashwarya Gaur |
| Address |
D.Y. Patil School Of Ayurveda, D.Y. Patil University, Sector-7, Nerul ,Navi Mumbai, 400706 |
| Type of Sponsor |
Other [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 Ashwarya Gaur |
D.Y. Patil School Of Ayurveda |
1st Floor, OPD no.- 7, Department of Kaumarbhritya, Block no. 10, Dr.D.Y. Patil University, School of Ayurveda, Sector-7, Nerul, Navi Mumbai, 400706
Thane
MAHARASHTRA |
9149153119
gaurashwarya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee Of Ayurveda D.Y.Patil Deemed To Be University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E441||Mild 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: Yashtimadhusadhit Ghrita, Reference: Ashtang sangraham, Uttar tantra, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Sabhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -with food), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Ghrita, Reference: Yoga Ratnakar, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Sabhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -With Food), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1: Childern Age Group Between 3-8 years.
2: Childern Between (-2 TO -3 SD) Weight For Age According To WHO. |
|
| ExclusionCriteria |
| Details |
1: Known Case Of Systemic Disorders
2: Childern <-3 SD (Standard Deviation ) and >-2 SD Weight foe Age According TO WHO. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief From Subjective Assessment Criteria i.e Daurbalya, Kshudha, Dhamani jala darshana, Sthula Parva . |
Baseline & after every 15 day for 2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 |
|
Date of First Enrollment (India)
|
14/07/2023 |
| 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="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
|
TITLE
OF DISSERTATION
" A COMPARITIVE
CLINICAL STUDY TO ASSESS THE EFFECT OF YASHTIMADHUSADHIT GHRITA AND ASHWAGANDHA
GHRITA IN KARSHYA W.S.R TO
UNDERWEIGHT IN CHILDREN." AIM AND OBJECTIVE
AIM- To compare the clinical efficacy of Yashtimadhu Sadhita Ghrita and Ashwagandha Ghrita in management of Karshya in children.
OBJECTIVE- 1. To review the literature of Karshya in children.
2. To study the mode of action of Yashtimadhu Sadhita Ghrita on Karshya in children. 3. To study the mode of action of Ashwagandha Ghrita on Karshya in children. 4. To compare the effect of Yashtimadhu Sadhita Ghrita and Ashwagandha Ghrita in Karshya in children. RESEARCH QUESTION
PRIMARY RESEARCH QUESTION : Does Yashtimadhu Sadhita Ghrita and Ashwangandha Ghrita have significant difference in the effect on karshya in children.
HYPOTHESIS
1. NULL HYPOTHESIS(H0)- There will be no significant difference in the effect on Karshya in children by the intervention of Yashtimadhu Sadhita Ghrita & Ashwagandha Ghrita. 2. ALTERNATIVE HYPOTHESIS(H1)- There will be significant difference in effect on Karshya in children by intervention of Yashtimadhu Sadhita Ghrita and Ashwagandha Ghrita. ASSESSMENT CRITERIA SUBJECTIVE PARAMETERS: 1 DAURBALYA 2 KSHUDHA 3DHAMNI JALA DARSHANA 4 STHULA PARVA OBJECTIVE PARAMETER 1 WEIGHT 2 HEIGHT 3 CHEST CIRCUMFERENCE 4 ABDOMINAL GIRTH 5 MID ARM CIRCUMFERENCE MATERIAL (GROUP A) YASHTIMADHUSADHIT GHRITA Yashtimadhu, Padmaka, Taleesh, Pippali, Utpala, Lodhra, Chandana, Sariva, Goghrita Dose- 2 to 7 ml according to weight (GROUP B) ASHWAGANDHAGHRITA Ashwagandha and Goghrita Dose- 2 to 7 ml according to weight
|