CTRI

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CTRI Number

CTRI/2024/01/061826 [Registered on: 24/01/2024] Trial Registered Prospectively

Last Modified On:

03/01/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

To study which drug is better whether Gambhariphal granules or Ashwagandha granules in the management of karshya (Underweight children).

Scientific Title of Study

A randomized controlled clinical study of Gambhariphal granules and Ashwagandha granules in the management of karshya(underweight) in children of age group between 6-12 years.

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 Arya Uttareshwar Gund
Designation	PG scholar
Affiliation	PDEAS college of Ayurveda and Research centre Nigdi
Address	PDEAS college of Ayurveda and Research centre Balrog Department third floor Nigdi pune Maharashtra 411044 INDIA Pune MAHARASHTRA 411044 India
Phone	9765325869
Fax
Email	aryagund79@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Madhavi Deodas
Designation	Professor and HOD
Affiliation	PDEAS college of Ayurveda and Research centre Nigdi
Address	PDEAS college of Ayurveda and Research centre Balrog Department third floor Nigdi pune Maharashtra Pune MAHARASHTRA 411044 India
Phone	9423010818
Fax
Email	drdeodasms@gmail.com

Details of Contact Person
Public Query

Name	Dr Madhavi Deodas
Designation	Professor and Hod
Affiliation	PDEAS college of Ayurveda and Research centre Nigdi
Address	PDEAS college of Ayurveda and Research centre Balrog department third floor Nigdi 411044 Pune Maharashtra Pune MAHARASHTRA 411044 India
Phone	9423010818
Fax
Email	drdeodasms@gmail.com

Source of Monetary or Material Support

PDEAS college of Ayurved And Research centre Nigdi pune

Primary Sponsor

Name	PDEAS college of Ayurveda and Research centre Nigdi pune
Address	PDEAS college of Ayurveda and Research centre sector 25 pradhikaran Nigdi pune Maharashtra
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Arya Uttareshwar Gund	Ayurveda Rugnalay and Sterling multispeciality hospital Nigdi pradhikaran pune	Vitthal rukhmini road sector 27 Kaumarbhritya OPD no 118 Nigdi pradhikaran pune Maharashtra Pune MAHARASHTRA	9765325869 aryagund79@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Chairperson Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E43\|\|Unspecified severe protein-caloriemalnutrition,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Gambhariphal , Reference: Bhavprakash , Route: Oral, Dosage Form: Khanda /Granules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Ashwagandha , Reference: Bhavprakash , Route: Oral, Dosage Form: Khanda /Granules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: -

Inclusion Criteria

Age From	6.00 Year(s)
Age To	12.00 Year(s)
Gender	Both
Details	Weight less than 80 percent for age Patients having clinical features like Daurbalya,Aruchi,kshudhaprachiti, Sthoolparva Children of age group between 6-12 years irrespective of the sex

ExclusionCriteria

Details

K/C/O Grahani Dosha
K/C/O systemic disorder like Carcinoma, Hepatitis,HIV, Tuberculosis
K/C/O Inborn Error of Metabolism
K/C/O endocrinal disorder like hyperthyroidism ,food allergy

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Alternation

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To study the efficacy of Gambhariphal granules for 60 days in the management of Karshya on the basis of their symptoms like Daurbalya,Aruchi etc.	60 days where follow up on 15th,30th,45th,60th day

Secondary Outcome

Outcome	TimePoints
To Observe the adverse effects if any	60 days where follow up on 15th,30th,45th,60th day

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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

Years="1"
Months="6"
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

Nutrition plays a great role in our daily life.Malnutrition has been identified as a significant clinical problem in India.Underweigjt can be defined as a child whose body weight is considered too low to be healthy.As per WHO underweight can be considered when proportion of children whose weight in relation to their age is below -2 standard deviations of the median of National Centre for Health Statistics reference.

Underweight can be correlated with karshya in Ayurveda where body gets emacciated gradually.Among the eight socially despicable persons as mentioned by Acharya charak karshya is said to be nutritional deficiency.Karshya is clinical entity presented with features like shushka sphik ,udar and greeva .All of these features are found in underweight children.Balya and Brimahan chikitsa is suggested for malnourished children in Ayurveda.

For this research Gambhariphal has been chosen described in Bhavprakash which possess properties like tridoshghna,brimhana,rasayana,Madhura rasa.Properties may help in breaking down samprapti of karshya and there by can arrest the progress of disease.Granule form has been choosen because it is easy to administration.