To evaluate the Safety and efficacy of Raughan Ikseer for symptomatic relief in Waja‘ al-AsnÄn (Toothache)

Phase 2

Not yet recruiting

• Conditions: Acute gingivitis, Toothache,

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

Brief Summary

This study is designed as a multicentric open trialin patients with Waja‘ al-AsnÄn(Toothache). Patients will receive the study drug  Raughan Ikseer, as local apploication twice daily for aperiod of 7 days. All the laboratory parameters will be recorded atbaseline and at the end of the study.

Composition ofRaughan Ikseer

| | | | |

| --- | --- | --- | --- |

|**S. No.**

**Unani Name**

**Botanical Name**

**Weight**

|1.

Kafoor Khalis

*Cinnamomum camphora*

25 g

|2.

Sat-e- Pudina

*Mentha arvensis*

10 g

|3.

Sat-e- Ajwayin

*Trachyspermum ammi*

10 g

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-03
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

• •Patients of either sex in the age group 18-65 years.
• •Patients having Waja‘ al-AsnÄn (Toothache) with or without any of the following symptoms: Waram al-Lisa (Gingival swelling) Humra al-Lisa (Gingival erythema) Nazf al-Lisa (Gingival bleeding) HassÄsiyat HarÄriyya (Thermal sensitivity) – Pain triggered by Cold or Heat SudÄ‘ (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 Waja‘ al-AsnÄn (Toothache)	7 DAYS

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessments for safety	ï‚· Improvement in the feeling of well-being of the patient

Trial Locations

Locations (6)

Clinical Research Unit (CRU), Kurnool; 🇮🇳 Kurnool, ANDHRA PRADESH, India

Regional Research Centre, Silchar; 🇮🇳 Cachar, ASSAM, India

Regional Research Institute of Unani Medicine Bhadrak; 🇮🇳 Bhadrak, ORISSA, India

Regional Research Institute of Unani Medicine, Chennai; 🇮🇳 Chennai, TAMIL NADU, India

Regional Research Institute of Unani Medicine, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE, PATNA; 🇮🇳 Patna, BIHAR, India

Clinical Research Unit (CRU), Kurnool

🇮🇳Kurnool, ANDHRA PRADESH, India

Hakim Jawadul Haq

Principal investigator

09502443555

cru.kurnool@gmail.com