To evaluate the Safety and efficacy of Unani formulations in Commom Cold

Phase 2

Recruiting

• Conditions: Acute nasopharyngitis [common cold], Nazla-e- HÄr (Common Cold),

• Registration Number: CTRI/2013/12/004257
• 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 ***Nazla-e- HÄr*** **(Common Cold).** After screening, Patients will be enrolled if they satisfy the inclusion and exclusion criteria.  The patients will be assessed clinically on follow up.  This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 1 week . Laboratory parameters for safety assessment will be conducted at baseline and end of study.

1-TukhmDhatura Siyah        (Datura stramoniumLinn.)    3 Parts

2-RewandChini                     (Rheumofficinale Baill.)      2 Parts

3-Zanjabil                                (Zingiberofficinale Roscoe) 1 Part

4-Samagh Arabi                      (Acacia nilloticaWilld.)        1 Part

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-13
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

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

Inclusion Criteria

All subjects should meet the following criteria: 1-Patients of either sex in the age group of 18-65 2- Patients of Nazla-e- HÄr (Common Cold) presenting with recent onset of any of the following symptoms: •KhushÅ«na al-Halaq (Sore throat) •Buhha al-Sawt (Hoarseness of Voice) •‘UtÄs (Sneezing/ Nasal irritation) •SudÄ‘ (Headache) •Su‘Äl (Cough) •Runny nose •I‘yÄ (Malaise) •Flushing of Face •With or without low grade fever (<102 0F).

Exclusion Criteria

• Patients will be excluded if they meet any of the following criteria: 1.
• Patients of acute or chronic lower respiratory tract infection like pneumonia, Bronchitis, Asthma and Bronchiectasis.
• Fever 102oF 3.
• Known cases of any other acute illness 4.
• Pregnant and lactating women 5.
• Known case of Renal/ Hepatic/ Cardiac impairment or the ailment needs long term therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Nazla-e- HÄr (Common Cold)	1 week

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	1 WEEK

Trial Locations

Locations (7)

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

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

Regional Research Centre (RRC), Silchar, Assam; 🇮🇳 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), Karimganj, Assam

🇮🇳Karimganj, ASSAM, India

DR WAHIDUZZAMAN

Principal investigator

03843267522

crukxj522@gmail.com