To evaluate the Safety and efficacy of Unani formulations in the treatment of Headache

Phase 2

Recruiting

• Conditions: Headache, Headache (SudÄ),

• Registration Number: CTRI/2015/03/005608
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary

This study is designed as a multicentric open trial in patients with **Arq Ajeeb in SudÄ‘ (Headache)****.**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on3rd and 7th day of treatment. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be one week. . Laboratory parameters for safety assessment will be conducted at baseline and end of study.

**Composition of** ***Arq Ajeeb***

| | | | |

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

|**S. No.**

**Unani Name**

**Botanical Name**

**Weight**

|1.

Kafoor

*Cinnamomum camphora*

20 g

|2.

Jauhar-e- Pudina

*Mentha arvensis*

20 g

|3.

Jauhar-e- Ajwayin

*Trachyspermum ammi*

10 g

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-03
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

•Patients of either sex with age 18-65 years •Patients having SudÄ‘ (Headache) with or without any of the following symptoms: Disturbed concentration Irritability Zu‘f al-IshtihÄ’ (Decreased appetite) I‘yÄ (Fatigue) Difficulty in falling asleep and staying asleep Mild sensitivity to light/ noise.

Exclusion Criteria

• •Headache does not respond to standard therapy •Headache accompanied by impaired neurological functions (loss of balance, weakness, numbness, or speech disturbances), double vision, seizures, mental disturbances, and loss of consciousness.
• •Headache accompanied by persistent nausea, vomiting, fever and stiff neck •History of recent head injury.
• •Known cases of any other acute illness.
• •Known cases of severe Renal/ Hepatic/ Cardiac ailments •Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Sudđ (Headache)	7 days

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety	7 days

Trial Locations

Locations (7)

Clinical Research Unit (CRU), Karimganj; 🇮🇳 Karimganj, ASSAM, India

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

Regional Research Centre (RRC), Silchar; 🇮🇳 Cachar, ASSAM, India

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

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

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

Regional Research Institute of Unani Medicine (RRIUM), Patna; 🇮🇳 Patna, BIHAR, India

Clinical Research Unit (CRU), Karimganj

🇮🇳Karimganj, ASSAM, India

DR WAHIDUZZAMAN

Principal investigator

03843267522

crukxj522@gmail.com