FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/02/017820 [Registered on: 26/02/2019] Trial Registered Prospectively
Last Modified On: 12/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Unani 
Study Design  Single Arm Study 
Public Title of Study   Treatment of Premature ejaculation (Early ejaculation of semen) with Unani medicine Majoon-e-Ispand  
Scientific Title of Study   Clinical Validation of Unani Pharmacopoeial Formulation Majoon-e-Ispand Sokhtani in SurÊ»a al-Inzāl (Premature Ejaculation) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SI/PE/MIS/CLNVAL/CCRUM/17-18  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Asim Ali Khan 
Designation  Director General 
Affiliation  Central Council for Research in Unani Medicine 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

South West
DELHI
110058
India 
Phone  01128525715  
Fax    
Email  unanimedicine@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naheed Parveen 
Designation  Assistant Director (Unani) 
Affiliation  Central Council for Research in Unani Medicine 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

South West
DELHI
110058
India 
Phone  9213511298  
Fax    
Email  ccrum507@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep Kumar 
Designation  Research Officer (Path) SIV 
Affiliation  Central Council for Research in Unani Medicine 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

South West
DELHI
110058
India 
Phone  8800263300  
Fax    
Email  drpradeepkumar2001@yahoo.com  
 
Source of Monetary or Material Support  
Infrastructural support : 1 Clinical Research Unit (CRU), Kerala 2. Clinical Research Unit (CRU), Burhanpur 3. Regional Research Institute of Unani Medicine (RRIUM), Bhadrak Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi 
 
Primary Sponsor  
Name  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-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 M A Waheed  Clinical Research Unit (CRU)  Edathala, Alwaye Research OPD Room (SurÊ»a al-Inzāl)
Ernakulam
KERALA 		 9347351749

mawaheed313@gmail.com 
Hkm Mujahid Sami  Clinical Research Unit (CRU)  Ganpati Naka, Burhanpur Research OPD Room (SurÊ»a al-Inzāl)
East Nimar
MADHYA PRADESH 		 9425415145

cruburhanpur@rediffmail.com 
Dr Abdur Rasheed  Regional Research Institute of Unani Medicine (RRIUM)  Chandbali by pass road, near rural police station Research OPD Room (SurÊ»a al-Inzāl)
Bhadrak
ORISSA 		 8895543162

rriumbdk_unani@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Clinical Research Unit, Burhanpur  Approved 
Clinical Research Unit, Kerala  Submittted/Under Review 
Regional Research Institute of Unani Medicine, Bhadrak  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N539||Unspecified male sexual dysfunction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Majoon-e-Ispand Sokhtani  5gm orally twice daily with water after meals for two weeks 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  The following criteria will be strictly followed for inclusion of cases in the study:
1. Men in the age group of 21-65 years
2. Men with a PEDT score > 11
3. Men with lifelong /Acquired PE meeting the evidence-based definition proposed by ISSM:
LPE
 IELT ≤1 min from the first sexual experience
 Inability to delay ejaculation
 Related negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy
APE
 A clinically significant reduction in IELT, often ≤3 min
 Lacking the ability to delay ejaculation
 Related negative personal consequences as similar with that of LPE 
 
ExclusionCriteria 
Details  The patients of SurÊ»a al-Inzāl (Premature ejaculation) with following conditions will be excluded from the study:
1. Patients with Erectile dysfunction
2. Major psychiatric disorders or cognitive impairments
3. Patients with history of intake of any drug causing sexual dysfunction and affecting psychological status
4. History of addiction (alcohol, drug abuse)
5. Patients with chronic diseases, requiring long term treatment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in sign and symptoms of SurÊ»a al-Inzāl (Premature Ejaculation)   2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Haematological and biochemical assessment for safety assessment.   Investigations will be done at baseline and end of treatment 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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 3 
Date of First Enrollment (India)   08/03/2019 
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)  Not Yet Recruiting 
Publication Details   Not yet. 
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 SurÊ»a al-Inzāl (Premature Ejaculation). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed at every week.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be two weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy. 

Composition of Majoon-e-Ispand Sokhtani

S.No.

Ingredients

Botanical / Chemical name

Part used

Quantity

1.

Ispand Sokhtani

Peganum harmala L.

Seeds

30 g

2.

Bisbasa

MyristicafragransH.

Aril/Seed covering

30 g

3.

Jauzbawa

Myristicafragrans H.

Seed

30 g

4.

Qaranfal

Syzygiumaromaticum L.

Flower buds

30 g

5.

Darchini

Cinnamomum zeylanicum B.

Bark

30 g

6.

Kunjad Siyah Muqashshar

Sesamum indicum L.

Seeds

40 g

7.

Asal / Qandsafaid

Honey / Sugar

 

600 g
 
Close