CTRI

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CTRI Number

CTRI/2025/04/084372 [Registered on: 08/04/2025] Trial Registered Prospectively

Last Modified On:

27/03/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Single Arm Study

Public Title of Study

Study on Effectiveness of Kushmandak Rasayana (An Ayurvedic Medicine) in Improving Nutrition in Moderately Malnourished Children Aged 4-9 Years

Scientific Title of Study

Effectiveness of Kushmandak Rasayana in the Management of Moderately Malnourished Children Aged 4-9 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 Renu Singh
Designation	Research Officer (Ayurveda)
Affiliation	Central Council for Research in Ayurvedic Sciences (CCRAS)
Address	61-65, opp. D Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi New Delhi DELHI 110058 India
Phone
Fax
Email	drrenusinghccras@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Prashant Shinde
Designation	Research Officer (Ayurveda)
Affiliation	Central Council for Research in Ayurvedic Sciences (CCRAS)
Address	61-65, opp. D Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi New Delhi DELHI 110058 India
Phone	9623011214
Fax
Email	drprashantccras@yahoo.com

Details of Contact Person
Public Query

Name	Vd Jaiprakash Ram
Designation	Research Officer (Ayurveda)
Affiliation	Regional Ayurved Research Institute, Ahmedabad
Address	Block A & D, Bahumali Bhavan, Asarva, Ahmedabad Ahmadabad GUJARAT 380004 India
Phone	7791834211
Fax
Email	jpram.vd@ccras.nic.in

Source of Monetary or Material Support

Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of Ayush, Government of India, JLNBCAHAB, No. 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi 110058, India

Primary Sponsor

Name	Central Council for Research in Ayurvedic Sciences CCRAS
Address	61-65, opp. D Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi, India Pincode 110058
Type of Sponsor	Government funding agency

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 4
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Kalpana Dattatray Dhuri	D Y Patil Deemed to Be University, School of Ayurveda, Mumbai	OPD no 7 Kaumarbhrutya OPD DYPATIL school of Ayurveda Sector 7, Nerul, Navi Mumbai Mumbai (Suburban) MAHARASHTRA	9321835616 kalpana.dhuri@dypatil.edu
Dr Yogita Kameshwar Shrivas	Datta Meghe Ayurvedic Medical College Hospital & Research Centre, Nagpur	Room No 04 Kaumarbhritya OPD Datta Meghe Ayurvedic Medical college, Hospital and Research centre,YCCE campus, Wanadongri, Hingna Nagpur MAHARASHTRA	7588747496 yogitashrivas@yahoo.co.in
Dr Nimesh Gunvantbhai Kachhiapatel	J. S. Ayurved Mahavidyalaya, Nadiad	Room No 133,Kaumarbhritya OPD P D Patel Ayurveda Hospital J S Ayurved Mahavidyalaya College Road Nadiad Kheda GUJARAT	9979890381 drnimesh71@yahoo.com
Dr Swapnil C Raskar	Parul Institute of Ayurved	Room No. 103, Kaumarbhritya OPD, Parul Ayurveda Hospital, Parul University, at post Limda, Tehsil Waghodia Vadodara GUJARAT	9726587013 swapnil.raskar@paruluniversity.ac.in

Details of Ethics Committee

No of Ethics Committees= 4
Name of Committee	Approval Status
Institutional Ethics Committee	Approved
INSTITUTIONAL ETHICS COMMITTEE	Approved
INSTITUTIONAL ETHICS COMMITTEE	Approved
MAGANBHAI ADENWALA MAHAGUJARAT UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:E41\|\|Nutritional marasmus. Ayurveda Condition: KARSYAMÂ (KEVALAVATA),

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Kushmandak Rasayan, Reference: AFI part 1, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: -Dose will be 5 gm upto 5 years of age, 10 gm for above 5 years of age

Inclusion Criteria

Age From	4.00 Year(s)
Age To	9.00 Year(s)
Gender	Both
Details	Children with weight for age z score between -2 SD and +3SD of the World Health Organization (WHO) weight for age growth standards i. Children of either sex; age group between 4-9 years ii. Children with weight-for-age between -2 SD and -3 SD of the World Health Organization (WHO) weight for age growth standards. iii. Parents or caregivers willing to provide a written informed consent form for the participation of their children.

ExclusionCriteria

Details

i. Children with Sever Acute Malnutrition
ii. Children with known case of Sickle Cell Disease (only SS pattern)
iii. Children with diagnosed cases of serious health issues like heart diseases, lung diseases, concurrent hepatic disorder, renal disorder, congenital anomalies, inborn errors of metabolism, malignancy, tuberculosis, HIV etc that might interfere with nutritional recovery
iv. Children with acute infections viz- respiratory tract infections, diarrhea, fever etc
v. H/o hypersensitivity to the trial drug or any of its ingredients.
vi. Patients who have completed participation in any other clinical trial during the past six months.
vii. Any other condition which the Investigator thinks may jeopardize the study.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
i. Change in weight for age Z score by using WHO child growth standards	Baseline, end of 3rd month, end of 6th month

Secondary Outcome

Outcome	TimePoints
i. Changes in the score of PedsQL inventory	Baseline, end of 3rd month and end of 6th month
ii. Incidence of treatment Emergent Adverse Events	Every Visit
iii. Assessment of the tolerability of Kushmandak Ramayana (Assessed through reported withdrawal of participants due to incidence of Treatment emergent adverse events (GIT-related AE specifically) during the study period	every Visit
iv. Assessment of treatment adherence through participant self-reported compliance log and used medication containers	30th day visit, 60th Day visit, 90th Day visit, 120th Day and 180th Day visit
v. Change in the laboratory parameters from baseline (Complete Blood Count, Liver Function Test, Kidney Function Test)	baseline, and 180th Day

Target Sample Size

Total Sample Size="540"
Sample Size from India="540"
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)

20/04/2025

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="2"
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

Malnutrition remains a significant issue in India, impacting a substantial proportion of the population, especially children. The study is planned to aassess the effectiveness of Kushmandak Rasayana in weight for age z score of moderately malnourished children aged 4-9 years. It is an open label single arm study. The study is multicentric will be carried out with the coordination of Regional Ayurveda Research Institute, Ahmedabad with four Ayurveda colleges from different states of India. The study will, be sponsored by CCRAS under SMART 2.0 programme.