To evaluate the Safety and efficacy of Raughan Ikseer for symptomatic relief in Wajaâ?? al-AsnÄ?n (Toothache)

Phase 2

• Conditions: Health Condition 1: K050- Acute gingivitisHealth Condition 2: null- Toothache

• Registration Number: CTRI/2015/02/005573
• Lead Sponsor: Central Council for Research in Unani Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 384

Inclusion Criteria

•Patients of either sex in the age group 18-65 years.

•Patients having Wajaâ?? al-AsnÄ?n (Toothache) with or without any of the following symptoms:

ï?§Waram al-Lisa (Gingival swelling)

ï?§Humra al-Lisa (Gingival erythema)

ï?§Nazf al-Lisa (Gingival bleeding)

ï?§HassÄ?siyat HarÄ?riyya (Thermal sensitivity) â?? Pain triggered by Cold or Heat

ï?§SudÄ?â?? (Headache)

Exclusion Criteria

•Toothache does not respond to standard therapy.

•Toothache accompanied by impaired neurological functions (loss of balance, weakness, numbness, or speech disturbances), double vision, seizures, mental disturbances, and loss of consciousness.

•Toothache accompanied by persistent nausea, vomiting, fever and stiff neck.

•Presence of a periodontal abscess as diagnosed from clinical examination of the painful tooth.

•Presence of concomitant oral pain due to any other condition such as soft-tissue lesions (e.g., aphthous/ traumatic ulcer, herpes labialis, acute necrotizing ulcerative gingivitis) or multiple hard-tissue (e.g., carious) lesions; pain due to other surgical procedures, injuries or dental surface sensitivity.

•Known cases of any other acute illness.

•Known cases of severe Renal/ Hepatic/ Cardiac ailments.

•Pregnant and lactating women.

•History of Hypersensitivity to the study drug or any of its ingredients.

•History of addiction (alcohol, drugs)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Wajaâ?? al-AsnÄ?n (Toothache)Timepoint: 7 DAYS

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessments for safety <br/ ><br>ï?· Improvement in the feeling of well-being of the patientTimepoint: 7 DAYS