| CTRI Number |
CTRI/2018/08/015405 [Registered on: 21/08/2018] Trial Registered Prospectively |
| Last Modified On: |
07/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Premature Ejaculation with Unani Medicine Majoon-e-Piyaz |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeal formulation Majoon-e-Piyaz in Surat Inzaal (Premature Ejaculation) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SI/PE/MP/CLNVAL/CCRUM 16-17 version 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| 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 (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Central Research Institute of Unani Medicine Lucknow 2. Clinical Reserch Unit Burhanpur 3 Clinical Reserch Unit Meerut Monetary Support: Central Council For Research In Unani Medicine |
|
|
Primary Sponsor
|
| Name |
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 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shamsul Arfin |
Central Research Institute of Unani Medicine |
Research OPD Room
Basha, Kursi Road
Lucknow
UTTAR PRADESH |
9450389873
crium_lko@yahoo.co.in |
| Dr Mohd Tariq Khan |
Clinical Research Unit |
Research OPD Room
Cantonment General Hospital, Begum Bridge (Soti Ganj)
Meerut
UTTAR PRADESH |
8266001184
crumeerut@gmail.com |
| Dr Noor Mohammad |
Clinical Research Unit |
Research OPD Room
S H Unani Tibbia College Ganpati Naka
West Nimar
MADHYA PRADESH |
8109462242
cruburhanpur@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine Lucknow |
Submittted/Under Review |
| Clinical Research Unit Burhanpur |
Submittted/Under Review |
| Clinical Research Unit Meerut |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Surat Inzaal (Premature Ejaculation) |
| Patients |
(1) ICD-10 Condition: N539||Unspecified male sexual dysfunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Majoon-e-Piyaz |
Majoon-e-Piyaz Semi solid
7g Twice daily oral To be taken 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 |
Both |
| Details |
The following criteria will be strictly followed for inclusion of cases in the study.
1. Male patients in the age group of 21 to 65 years.
2. Men with an IELT ( Intra-vaginal ejaculatory latency time) of less than 1 minute will be included in the study
3. Men with a PEDT Score >11
|
|
| ExclusionCriteria |
| Details |
The patients of Surat-e-Inzal (Premature ejaculation) with following conditions will be excluded from the study:
1. Patients with Erectile Dysfunction
2. Patients with diseases requiring long term treatment
3. Patients with cognitive impairments
4. History of addiction (smoking, alcohol, drugs)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the sign and symptoms of NisyÄn (Amnesia) |
Two Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hematological and biochemical assessments for safety |
2 weeks |
|
|
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 2 |
|
Date of First Enrollment (India)
|
23/08/2018 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a multicentric open trial in patients with Surat Inzaal (Premature Ejaculation) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at weekly. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 2 weeks. . Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.Composition
of Majoon -e- Piyaz:
|
S. No.
|
Ingredients
|
Botanical / Chemical Name
|
Quantity
|
|
1.
|
Tudri
Surkh
|
Mathiola
incana
|
35
g
|
|
2.
|
Tudri
Safaid
|
|
35
g
|
|
3.
|
Salab Misri
|
Orchis
latifolia
|
35g
|
|
4.
|
Behman
Surkh
|
Salvia
haematodes
|
35
g
|
|
5.
|
Behman
Safaid
|
Centaurea
behman
|
35
g
|
|
6.
|
Zanjabeel
|
Zingiber
officinale
|
35
g
|
|
7.
|
Tukhm-e-Piyaz
|
Allium cepa
|
35
g
|
|
8.
|
Tukhm-e-Turb
|
Raphanus
sativus
|
35
g
|
|
9.
|
Tukhm-e-Gandana
|
Alliumascalonicum
|
35
g
|
|
10.
|
Tukhm-e-Shalgham
|
Brassia rapa
|
35g
|
|
11.
|
Talmakhana
|
Asteracanthna
longifolia
|
35g
|
|
12.
|
Musli
Safaid
|
Chlorophytum
arundinaceum
|
35g
|
|
13.
|
Musli
Siyiah
|
Curculigo
orchioides
|
35g
|
|
15.
|
Aab-e-Piyaz
|
Allium cepa (aqueous
Extract)
|
1.5
litter
|
|
16.
|
Asal/Quand
Safaid
|
|
1.5kg
|
|