A CLINICAL STUDY COMPARING THE EFFICACY OF APAMARGA AND KARVIRA(SHWET)PRATISARANEEYA TEEKSHNA KSHAR APPLICATION IN THE MANAGEMENT OF ARDRA ARSHA(INTERNAL HAEMARRHOID)

Phase 2

Not yet recruiting

• Conditions: Unspecified hemorrhoids. Ayurveda Condition: ARSAH,

• Registration Number: CTRI/2025/03/082935
• Lead Sponsor: National Institute of Ayurveda

Brief Summary

Th study compares the efficacy of Apamarga Pratisarneeya Teekshna Kshar and Karvira (Shwet) Pratisarneeya Teekshna Kshar in managing Ardra Arsha (second and third degree internal haemorhoids) through a ramomized comparative trial of 30 patients. It is assessed by sujective parameters like pain, bleeding and quality of life and objective parameters like sphincter tone and post operative scars etc.  This study aims to evaluate the efficacy of shwet Karavira Pratisaraniya Teekshna Kshara, an unexplored preparation known for its ease of application, storage, and transportation, in treating Arsha when compared to the proven management by  Apamarga Pratisarneeya Teekshna Kshar.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-05
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with Arsha categorized as Mridu, Prasrita,Avagada and Uchchhrita Patients with Arsha of Pittaja and Raktaja origin.
• Diagnosed cases of hemorrhoids of the second and third degree.

Exclusion Criteria

• Patients with concurrent systemic illnesses such as uncontrolled Diabetes mellitus, Hypertension, Malignancy, Hepatitis B, Tuberculosis, and Retrovirus positivity.
• Patients with first and fourth-degree internal piles.
• Patients with external hemorrhoids and other associated Ano-rectal diseases.
• Patients with infective and neoplastic conditions of the rectum, rectal prolapse, pelvic pathology and pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Assessment Criteria viz Ruja (Post-operative pain) by the help of VAS (Visual Analogue Scale )(1,7,15,21,28), Rakta Srava (Bleeding) – Amount and Frequency (Likert Scale)(1,7,15,21,28), Video rectoscopy(pictosal), Anal sphincter tonicity (measured by Hemantha Kumar Modified Sphincterometer)	Changes in Assessment Criteria viz Ruja (Post-operative pain) by the help of VAS (Visual Analogue Scale ) will be donw at 1st,7th,15th,21st and 28th day, Rakta Srava (Bleeding) – Amount and Frequency (Likert Scale)will be assessed at 1st,7th,15th,21st and 28th day, Video rectoscopy(pictosal) will be done at 28th day, Anal sphincter tonicity (measured by Hemantha Kumar Modified Sphincterometer) will be assessed at 28th day

Secondary Outcome Measures

Name	Time	Method
QOL( Quality of life )- S.F. – 12	Assessment done at the end of 28th day

Trial Locations

Locations (1)

National Institute of Ayurveda Deemed to be University Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute of Ayurveda Deemed to be University Jaipur

🇮🇳Jaipur, RAJASTHAN, India

Dr Priti Beladar

Principal investigator

7523869026

pritibind68@gmail.com