Effect of Kumarabharana Rasa in children with chronic tonsillitis

Phase 2/3

Not yet recruiting

• Conditions: Chronic tonsillitis

• Registration Number: CTRI/2017/03/008050
• Lead Sponsor: Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital

Brief Summary

This study is an open labelled multicentric prospective clinical study to assess the effectiveness of Kumarabharana Rasa in recurrent upper respiratory tract infections with special reference to chronic tonsillitis in children. The subjects were given tablets of 500 mg, before food in the morning once a day mixed with honey orally for a period of 60 days on empty stomach. The primary outcome measures will be Enlargement of tonsils (Kathinashotha), Hyperemia (Ragatwa), Dysphagia (Galoparodha), Halitosis (Mukhadaurgandhya) and Enlargement of lymph nodes (Lasikagranthi Vriddhi). The changes in Haemoglobin%, Total leukocyte count, Differential leukocyte count, Erythrocyte sedimentation rate and Absolute Eosinophil Count will be noted.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-08-03
• Study Start: 2018-02-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Children of both genders between 5-10 years of age, who were suffering from repeated attacks of tonsillitis (chronic) in past year.
• Those participants whose parents are ready to sign the consent form and allow their children to participate in the clinical trial will be included.

Exclusion Criteria

• Patients with acute tonsillitis, peritonsillar abscess, tonsillar cyst, tonsillolith or with any other systemic disorders.
• Also the patients who have taken systemic steroids and/or antibiotics in the past four weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Enlargement of tonsils (Kathinashotha), Hyperemia (Ragatwa), Dysphagia (Galoparodha), Halitosis (Mukhadaurgandhya) and Enlargement of lymph nodes (Lasikagranthi Vriddhi).	60 days

Secondary Outcome Measures

Name	Time	Method
Changes in Haemoglobin%, Total	leukocyte count, Differential leukocyte count, Erythrocyte sedimentation rate and

Trial Locations

Locations (1)

SDM College of Ayurveda and Hospital; 🇮🇳 Hassan, KARNATAKA, India

SDM College of Ayurveda and Hospital

🇮🇳Hassan, KARNATAKA, India

Dr Shailaja U

Principal investigator

9448816433

rao.shaila@gmail.com