To evaluate the Safety and efficacy of two Unani formulations in the treatment of overactive bladder.

Phase 2

Recruiting

• Conditions: Bladder disorder, unspecified, Zof-e-Masana (Overactive Bladder),

• Registration Number: CTRI/2013/12/004258
• 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 Zof-e-Masana (Overactive Bladder). Patients will receive the study drugs   Majoon Flasfa and   Majoon Masik ul baul in a dose of 7 gms each once a day. The total duration of treatment will be 12 weeeks. All the laboratory parameters will be recorded at baseline and at the end of the study. Clinical followups will be done at 1st, 4th, 8th and 12th week.

**Composition of MAJOONFALASIFA**

1. Maweez Munaqqa                                                                                                     450g

2.     Zanjabeel                                                                                                                  150g

3.     Filfil siyah                                                                                                                  150g

4.     Filfil Daraz                                                                                                                150g

5.     Darchini                                                                                                                    150g

6.     Amla                                                                                                                          150g

7.     Post e Balela                                                                                                            150g

8.     Sheetraj Hindi                                                                                                         150g

9.     Zarawand Madahraj                                                                                             150g

10.          SalabMisri                                                                                                               150g

11.            Maghze Chilgoza                                                                                                   150g

12.           Bekhe Babuna                                                                                                        150g

13.            Maghze Narjeel                                                                                                     150g

14.                 Tukhme Babuna                                                                                                    75g

15.              Asalor Qand e Safaid                                                                                            7kg

 **Composition of MAJOONMASIKUL BAUL**

1.     Aqaqia                                                                                                                       15g

2.     Gulnar Farsi                                                                                                             15g

3.     Habb ul Aas                                                                                                              12g

4.     Sandal Safaid                                                                                                           10g

5.     Sandal Surkh                                                                                                           10g

6.     Adas Surkh                                                                                                               10g

7.     Charaita Shireen                                                                                                     10g

8.     Tukhm e Hummaz                                                                                                 10g

9.     Samagh e Arabi                                                                                                      10g

10.     Tabasheer                                                                                                               10g

11.     Kundur                                                                                                                      5g

12.  Julab                                                                                                                          Q.S

Detailed Description

Not available

Study Timeline

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

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1.Age- more than 18 yrs and upto 65 yrs 2.Gender- both 3.History of the following symptoms for more than six months •Urgency of urine •Incontinence •Dysuria.

Exclusion Criteria

Patients with Bladder calculus 2.Patients withUrinary tract infections 3.Patients with Benign Prostrate Hypertrophy 4.Patients with Uterine prolapse 5.Patients with Rectocele/cystocele 6.Patients with Cystitis 7.Patients with Diabetes Mellitus 8.Patients with Hypertension 9.Pregnant and lactating females 10.Neoplasm 11.Patients with Hepatic/Cardiac diseases 12.Medications (anticholinergic, antidepressant, psychotropic, or alpha-blocker) 13.Patients with History of any Spinal cord injury.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvements in signs and symptoms of Hypertension	12WEEKS

Secondary Outcome Measures

Name	Time	Method
Hematological and biochemical assessments for safety

Trial Locations

Locations (2)

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

REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE; 🇮🇳 JAMMU, & KASHMIR, India

Central Research Institute of Unani Medicine (CRIUM), Hyderabad

🇮🇳Hyderabad, ANDHRA PRADESH, India

DR MOHD ISMAIL

Principal investigator

040-23810246

mohammedismail5654@yahoo.in