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CTRI Number  CTRI/2013/12/004258 [Registered on: 30/12/2013] Trial Registered Retrospectively
Last Modified On: 03/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the Safety and efficacy of two Unani formulations in the treatment of overactive bladder.  
Scientific Title of Study   Validation of Unani Pharmacopoeial formulations in Zof-e-Masana (Overactive Bladder) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR ABDUL HANNAN 
Designation  Joint Director (Unani) 
Affiliation  Central Council for Research in Unani Medicine (CCRUM),  
Address  Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
New Delhi
DELHI
110058.
India 
Phone  011-28521981  
Fax  011-28522965  
Email  ccrum605@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR ABDUL HANNAN 
Designation  Joint Director (Unani) 
Affiliation  Central Council for Research in Unani Medicine (CCRUM),  
Address  Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
New Delhi
DELHI
110058.
India 
Phone  011-28521981  
Fax  011-28522965  
Email  ccrum605@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR ABDUL HANNAN 
Designation  Joint Director (Unani) 
Affiliation  Central Council for Research in Unani Medicine (CCRUM),  
Address  Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
New Delhi
DELHI
110058.
India 
Phone  011-28521981  
Fax  011-28522965  
Email  ccrum605@gmail.com  
 
Source of Monetary or Material Support  
Infrastructural support : 1 Central Research Institute of Unani Medicine (CRIUM), Hyderabad 2. Central Research Institute of Unani Medicine(CRIUM), Lucknow 3. Regional Research Institute of Unani Medicine(RRIUM), Srinagar Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi  
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine CCRUM New Delhi 
Address  Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058.  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR MOHD ISMAIL  Central Research Institute of Unani Medicine (CRIUM), Hyderabad  AG Colony road, Erragadda, Hyderabad- 500038
Hyderabad
ANDHRA PRADESH 		 040-23810246
040-23811495
mohammedismail5654@yahoo.in 
DR M A KHAN  REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE  Central Research Institute of Unani Medicine (CRIUM), Lucknow
Lucknow
UTTAR PRADESH 		 0522-2361720
0522-2732088
khanmaqboolahmed@gmail.com 
DR SHAISTA UROOJ  REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE  University of Kashmir, Srinagar-190006
Srinagar
JAMMU & KASHMIR 		 0194-2421604
0194-2421604
rrium.srinagar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
CRIUM HYDERABAD INSTITUTIONAL ETHICS COMMITTE  Approved 
CRIUM LUCKNOW INSTITUTIONAL ETHICS COMMITTEE  Approved 
RRIUM SRINAGAR INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N329||Bladder disorder, unspecified, Zof-e-Masana (Overactive Bladder),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Majoon Flasfa 2. Majoon Masik ul baul   1. Majoon Filasfa, 7 gm orally in the morning 2. Majoon Masikul Baul 7 gm orally in the morning. Duration of therapy is 12 weeks All the medicines will be give to the same patient 
Comparator Agent  NIL  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvements in signs and symptoms of Hypertension
 		 12WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
Hematological and biochemical assessments for safety
 		 12 WEEKS 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   02/11/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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 MAJOON FALASIFA

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.          Salab Misri                                                                                                               150g

11.            Maghz e Chilgoza                                                                                                   150g 

12.            Bekh e Babuna                                                                                                        150g

13.             Maghz e Narjeel                                                                                                     150g

14.                 Tukhm e Babuna                                                                                                    75g

15.               Asal or Qand e Safaid                                                                                            7 kg

 

Composition of MAJOON MASIKUL 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

 
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