A randomized controlled clinical trial to evaluate the efficacy of Ajamoda Arka in Udarshool in Ksheerapavastha.

Phase 2/3

Not yet recruiting

• Conditions: Disease of digestive system, unspecified. Ayurveda Condition: ADHMANAM, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system. Ayurveda Condition: Udarshool(उदरशूल),

• Registration Number: CTRI/2023/07/055763
• Lead Sponsor: Dr Surabhi Arun Yadgire

Brief Summary

This study is randomised controlled clinical trail study to evaluate the efficacy of Ajamoda Arka in Udarshool in Ksheerapavstha. Study will be carried in Kaumarbhritya OPD of Yashwant ayurvedic College and Hospital kodoli . The observation would be drawn on the basis of signs after treatment given .

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-08
• Last Update Posted: 2023-07-26

Recruitment & Eligibility

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

Inclusion Criteria

• 1)Children of Ksheerapavastha i.e. 0-1 years irrespective of Gender.
• 2. Patients having at least any two of the following symptoms of udarshool, like excessive cry, refusal to feed, irritability, abdominal distension or tenderness, etc.
• As mentioned in Ayurveda classics (Kaashyap samhita) and according to modern textbooks.
• 3. Patients having history of crying for more than 3 hrs/day, for more than 3 days in week, for at least 1 week.
• OR patients having history of at least any two of the following symptoms of udarshool, like excessive cry, refusal to feed, irritability, abdominal distension or tenderness, etc.

Exclusion Criteria

• 1. Udarshool associated with fever, vomiting, diarrhoea, constipation, acute infectious diseases like Gastro intestinal tract infections, urinary tract infections etc.
• 2. Known case of congenital anomalies.
• 3. Patient having food allergies like lactose intolerance, IEM etc.
• 4. Failure to thrive.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare efficacy of Shunthi Arka with Avartani Arka 0.16ml/kg/day Vyanodane in Udarshool in Ksheerapavastha for 5 days.	To compare efficacy of Shunthi Arka with Avartani Arka 0.16ml/kg/day Vyanodane in Udarshool in Ksheerapavastha for 5 days.

Secondary Outcome Measures

Name	Time	Method
To study the adverse effect of Shunthi Arka if any.	5 days

Trial Locations

Locations (1)

Yashwant Ayurvedic College; 🇮🇳 Kolhapur, MAHARASHTRA, India

Yashwant Ayurvedic College

🇮🇳Kolhapur, MAHARASHTRA, India

Dr Surabhi Arun Yadgire

Principal investigator

7030449657

surabhiyadgire@gmail.com