To evaluate the Safety and efficacy of Unani formulations in the treatment of (Pustules/Boils)

Phase 2

Recruiting

• Conditions: Other specified local infections of the skin and subcutaneous tissue,

• Registration Number: CTRI/2014/01/004283
• 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 **Busoor-e-Jild (Pustules/Boils)** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The clinical follow-up will be carried out weekly for the 1st month and every 2 weeks for the rest of the study.This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 06 weeks. . Laboratory parameters for safety assessment will be conducted at baseline and end of study.

**Composition of Majoon-e-Usba**

1.    Sana                                        80g

2.    Sandal Surakh                         60 gm.

3.    Sandal Safaid                          60 gm.

4.    Chobchini                                60 gm.

5.    Gul-e-Surkh                                      60 gm.

6.    Darchini                                  40 gm.

7.    Kababchini                              40 gm.

8.    Gaozaban                                40 gm.

9.    Atimoon                                  40 gm.

10.                       Bisfayaj                                   40 gm.

11.                       Post-e-Balela                           20 gm.

12.                       Sumbul-ut-Teeb                       20 gm.

13.                       Halela Siyah                                      15 gm.

14.                       Post-e-HalelaZard                             10 gm.

15.                       Asal OR QandSafaid              2 kg.

**Sharbat Murakkab Musaffi Khoon**

1.     Burada Aabnoos                                                                     50g.

2.     Burada Sheesham                                                                             50g.

3.     Burada Sandal Surkh                                                              100g.

4.     Burada Sandal Safaid                                                             50g.

5.     Barg e Hina                                                                             50g

6.     Barg e Neem                                                                            250g

7.     Brahm dandi                                                                          50g

8.     Post Halela Zard                                                                      50g.

9.     Chiraita talkh                                                                          50g.

10.                       Sarphoka 50 g.                                                                        50g

11.                       Shahtara 100 g                                                                        50g

12.                       Unnab                                                                                      250g.

13.                       Gul Mundi                                                                               50g

14.                       Gul Neelofer                                                                            50g

15.                                                                                                                                   Neel Kanthi                                                     50g

16.                       Halela Siyah neem Kofta                                                                   50g

17.                       Water                                                                                               5ltrs

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-11
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Patients of either sex in the age group of 5 to 60 years.
• 2.Frequent occurrence of the following 3.Vesicles (a vesicle is a small blister, as on the skin.
• Vesicles are less than .5 centimeters in diameter) 4.Papules (Small solid rounded bumps rising from the skin that are each usually less than 1 centimeter in diameter (less than 3/8 inch across) 5.Pustules (Small solid rounded bumps rising from the skin that are each usually less than 1 centimeter in diameter (less than 3/8 inch across) 6.Macules (Flat , distinct, colored area of the skin less than 1 cm in diameter).

Exclusion Criteria

• Age 5 years and 60 years 2.Patients with diseases/ disorders requiring long term treatment 3.Patients with Diabetes mellitus 4.Patients with other inflammatory skin conditions like localized abscess/ carbuncles/ boils.
• 5.Pregnancy and Lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms	6 WEEKS

Secondary Outcome Measures

Name	Time	Method
Hematological and biochemical assessments for safety	6 WEEKS

Trial Locations

Locations (3)

Clinical Research Unit, Burhanpur; 🇮🇳 Nimar, MADHYA PRADESH, India

Regional Research Centre Allahabad; 🇮🇳 Allahabad, UTTAR PRADESH, India

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

Clinical Research Unit, Burhanpur

🇮🇳Nimar, MADHYA PRADESH, India

Dr Mujahid Sami

Principal investigator

09827541428

mahajankk@rediffmail.com