CTRI

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CTRI Number

CTRI/2025/05/086116 [Registered on: 01/05/2025] Trial Registered Prospectively

Last Modified On:

30/04/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Crossover Trial

Public Title of Study

The Benefits of Dugdhika Churna for Managing Childhood Karshya

Scientific Title of Study

A Randomized controlled clinical trial to study the effect of dugdhika churna in the management of karshya in school aged children

Trial Acronym

Nill

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Punam Bhagwan Tupkar
Designation	PG kaumarbhritya scholar
Affiliation	SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri
Address	Department of Kaumarbhritya SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri Nashik MAHARASHTRA 422403 India
Phone	7559251409
Fax
Email	punamtupkar51@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Vijay Suryawanshi
Designation	HOD and Professor
Affiliation	SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri
Address	Department of Kaumarbhritya SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri Nashik MAHARASHTRA 42203 India
Phone	9420373110
Fax
Email	suvisa65@gmail.com

Details of Contact Person
Public Query

Name	Dr Vijay Suryawanshi
Designation	HOD and Professor
Affiliation	SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri
Address	Department of Kaumarbhritya SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri Nashik MAHARASHTRA 422403 India
Phone	9420373110
Fax
Email	suvisa65@gmail.com

Source of Monetary or Material Support

OPD andIPD of kaumarbhritya department of smbt ayurvedic college and hospital Nandi hills dhamangaonbigatpuri nashik maharashtra

Primary Sponsor

Name	Self Punam Bhagwan Tupkar
Address	Department of kaumarbhritya SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri,Nashik 422403
Type of Sponsor	Other [Self]

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 Punam Bhagwan Tupkar	SMBT Ayurved Medical Collage, Igatpuri, Nashik	OPD No 17 Department of kaumarbhritya SMBT Ayurved Collage and Hospital Dhamangaon,Igatpuri, Nashik 422403 Nashik MAHARASHTRA	7559251409 punamtupkar51@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Ethical Committee of the College	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:G\|\|Mental Health. Ayurveda Condition: KARSYAM (KEVALAVATA),

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: DUGDHIKA CHURNA, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Grasantara bhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Vidari Churna, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Honey), Additional Information: -

Inclusion Criteria

Age From	6.00 Year(s)
Age To	12.00 Year(s)
Gender	Both
Details	1.Patient of both genders between age group of 6 years to 12 years 2.Patient will be selected irrespective of Gender, caste, socio-economic status. 3.Patient with poor weight gain ,lean thin body as per IAP ( Grade 1) classification of underweight.

ExclusionCriteria

Details

1. Patient suffering from severe malnutrition(grade2
grade 3 and grade 4).
2. Patients with congential anomaly.
3. Patients with physical disability.
4. patients suffering from chronic disorder.
5. patients suffering from kwashirkar and marasmus.

Method of Generating Random Sequence

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

Method of Concealment

Case Record Numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1.Increase in Body Weight 2.Increase in Body Height 3.BMI	15-20 Days

Secondary Outcome

Outcome	TimePoints
1.Vyayam sauhityam 2.Sauhityam satvam 3.Agni 4.Daurbalya 5.Increase in Body Height ,Weight and BMI	45-60 Days

Target Sample Size

Total Sample Size="70"
Sample Size from India="70"
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)

11/05/2025

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="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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

Study Summary:

Aim: To study the effect of Dugdhika Churna in the management of Karshya (emaciation or underweight) in children aged 6 to 12 years.

Primary Objective: To evaluate the effect of Dugdhika Churna on Karshya in children, focusing on subjective and objective parameters of malnutrition after 2 months of treatment.

Background: Dugdhika Churna is an Ayurvedic herbal formulation traditionally used to manage Karshya, a condition characterized by malnutrition, growth impairment, and weakness, particularly in school-aged children. The formulation is believed to have rejuvenating, digestive, and appetite-enhancing properties, aiding in improved nutritional status and healthy weight gain.

Key Outcomes:

Increased body weight and improved growth patterns (height, BMI).
Enhanced appetite and digestion, leading to better nutrient absorption.
Improvement in biochemical markers like hemoglobin and serum albumin, reflecting better nutritional status.
Secondary outcomes include improvements in cognitive function, school performance, immune function, and overall quality of life.

Study Design:

Monitoring at different time points: Every 15 Days to assess the long-term effectiveness of Dugdhika Churna in managing Karshya.

Hypotheses:

Null Hypothesis: Dugdhika Churna has no effect on Karshya in children after 2 months of treatment.
Alternate Hypothesis: Dugdhika Churna is effective in treating Karshya in children after 2 months of treatment.

Variables:

Dependent Variable: Signs and symptoms of malnutrition (e.g., weight, height, BMI, biochemical markers).
Independent Variable: Drug (Dugdhika Churna), dosage, time, and duration of treatment.

Selection Criteria:

Inclusion Criteria:
- Children aged 6 to 12 years of both genders.
- Patients selected irrespective of gender, caste, and socio-economic status.
Exclusion Criteria:
- Children with severe malnutrition (Grade 3 and Grade 4).
- Children with congenital anomalies.
- Children with physical disabilities.

Malnutrition: Malnutrition refers to inadequate intake, poor absorption, or excessive loss of nutrients, leading to undernutrition. Overnutrition, resulting from overindulgence or excessive intake, is also considered a form of malnutrition. Protein-energy malnutrition is often used interchangeably with undernutrition.