Effect of Unani medicine Itrifal Ustukhudus in Nazla e Muzmin (Chronic Rhinosinusitis)

Phase 2

Recruiting

• Conditions: Chronic sinusitis, unspecified, Nazla e Muzmin (Chronic Rhinosinusitis),

• Registration Number: CTRI/2018/10/016178
• Lead Sponsor: Central Council for Research in Unani Medicine

Brief Summary

This study is designed as a multicentric open trial in patients with**Nazla e Muzmin (Chronic Rhinosinusitis)** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinicallyevery fifteen days. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be six weeks. Laboratory parameters for safety assessment will be conducted at baseline, first follow up and on completion ofthe protocol therapy.

**Compositionof *Itrifal ustukhudus***15

| | | | |

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

|**S. No.**

**Ingredients**

**Botanical / Zoological Name**

**Quantity**

|1.

Post-e-Halela zard

*Terminalia chebula*

100gm

|2.

Post –e-Halela Kabuli

*Terminalia chebula*

100gm

|3.

Halela Siyah

*Terminalia chebula*

100 gm

|4.

Post-e-Balela

*Terminalia bellerica*

100 gm

|5.

Aamla

*Embilica officinalis*

100 gm

|6.

Gul-e-surkh

*Rosa damescera*

100 gm

|7.

Ustukhudus

*Lavendula stoechas*

100 gm

|8.

Bisfayej

*Polypodium vulgare*

100 gm

|9.

Aftimoon

*Cuscuta reflexa*

100 gm

|10.

Kishmish

*Vitis vinifera*

100 gm

|11.

Roghan-e-zard

Clarified butter

20 gm

|12.

Qand safaid

Sugar

3kg

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-25
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 1.Patients of any in the age group of 19 to 60 years 2.
• Duration of disease >12 weeks 3.

Exclusion Criteria

• Rhinosinusitis /Sinusitis of < 12 weeks 2.
• Deviated Nasal septum 3.Nasal polyps 4.
• Local pathology such as mucocele, cyst, antrochoanal polyp, facial trauma, radiation injury, or birth defect •Diabetes mellitus and any other illness requiring long term treatment •Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of SNOT-22 scores	6 weeks
Improvement in signs and symptoms of Zimad e Bars of Nazla e Muzmin (Chronic Rhinosinusitis)	6 weeks

Secondary Outcome Measures

Name	Time	Method
Resolution of findings of X –ray PNS	at baseline and on completion of the protocol therapy ie after 6 weeks

Trial Locations

Locations (2)

Central Research Institute of Unani Medicine; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Regional Research Institute of Unani Medicine; 🇮🇳 JAMMU, & KASHMIR, India

Central Research Institute of Unani Medicine

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Mohd Arshad II

Principal investigator

09415793159

drmarshad93@gmail.com

Dr S Gulnawaz Ahmad

Principal investigator

09848716693

skgulnawaz@gmail.com