The Benefits of Dugdhika Churna for Managing Childhood Karshya

Phase 3

Not yet recruiting

• Conditions: Mental Health. Ayurveda Condition: KARSYAM (KEVALAVATA),

• Registration Number: CTRI/2025/05/086116
• Lead Sponsor: Self Punam Bhagwan Tupkar

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-30
• Study Start: 2025-11-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3.BMI	15-20 Days
1.Increase in Body Weight	15-20 Days
2.Increase in Body Height	15-20 Days

Secondary Outcome Measures

Name	Time	Method
1.Vyayam sauhityam	2.Sauhityam satvam

Trial Locations

Locations (1)

SMBT Ayurved Medical Collage, Igatpuri, Nashik; 🇮🇳 Nashik, MAHARASHTRA, India

SMBT Ayurved Medical Collage, Igatpuri, Nashik

🇮🇳Nashik, MAHARASHTRA, India

Dr Punam Bhagwan Tupkar

Principal investigator

7559251409

punamtupkar51@gmail.com