Clinical evaluation of the effect of a classical siddha drug akkara ennai for the treatment of Oral Ulcer

Phase 2

Completed

• Conditions: Other diseases of lip and oral mucosa,

• Registration Number: CTRI/2019/06/019921
• Lead Sponsor: A Arumuga kani

Brief Summary

The Present study is single arm clinical trial to access the efficacy of akkara eṇṇey for the treatment of uḷ akkaram 

In this trial 40 patients will be recruited and the trial drug will be administered 7.5 ml twice a day for the period of 5-7 days.

Primary outcome will be accessed by pain.Secondary outcome are reduction in size of ulcer and duration of ulcer.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-28
• Study Completion: 2020-03-24
• Last Update Posted: 2020-06-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• subjects with any of followimg symptoms will be included in the study 1.
• ulceration in oral cavity 2.
• Coated tongue 3.
• Running nose 4.
• Excessive thirst 6.

Exclusion Criteria

• The diseases which required immediate medical attension such as 1.
• Oral cancer 2.
• Oral Candidiasis 3.
• Oral thrush due to HIV will not be included from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Pain.	1-2 days.
2.Fever.	1-2 days.
3.Coated Tongue.	1-2 days.

Secondary Outcome Measures

Name	Time	Method
1.Ulcer size reduction 2.Excessive Thirst	3.Running Nose

Trial Locations

Locations (1)

Government siddha medical college and hospital,; 🇮🇳 Tirunelveli, TAMIL NADU, India

Government siddha medical college and hospital,

🇮🇳Tirunelveli, TAMIL NADU, India

A Arumuga Kani

Principal investigator

9500458608

drkaniabinesh@gmail.com