| CTRI Number |
CTRI/2009/091/000012 [Registered on: 03/02/2009] |
| Last Modified On: |
04/10/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the effects of 2 herbal products as dietary supplements for Male Sexual Health |
|
Scientific Title of Study
|
A triple blind, randomized, double dummy, prospective placebo controlled dose determination study to investigate the safety and efficacy of E-MA-H and E-MA-HP capsules as a dietary supplement for Male Sexual Health. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
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|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mugdha Kulkarni |
| Designation |
|
| Affiliation |
|
| Address |
203, Morya Landmark 1, Off. New Link Road, Andheri (west), Mumbai-400053
203, Morya Landmark 1, Off. New Link Road, Andheri (west), Mumbai-400053
Mumbai
MAHARASHTRA
400053
India |
| Phone |
022-42172306 |
| Fax |
02266941179 |
| Email |
nprd@exoticnatural.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Mugdha Kulkarni |
| Designation |
|
| Affiliation |
|
| Address |
203, Morya Landmark 1, Off. New Link Road, Andheri (west), Mumbai-400053
203, Morya Landmark 1, Off. New Link Road, Andheri (west), Mumbai-400053
Mumbai
MAHARASHTRA
400053
India |
| Phone |
022-42172306 |
| Fax |
02266941179 |
| Email |
nprd@exoticnatural.com |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
Modification(s)
|
| Name |
Exotic Naturals |
| Address |
203, Morya Landmark, Off. New Link Road, Andheri (West), Mumbai-400053. |
| Type of Sponsor |
Other [Herbal company] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manoj Chaudhary |
169, Parvati gaon, Bhagirathi Medical Foundation |
,-400009
Pune
MAHARASHTRA |
9225571450
020-24329465
aushadh_manoj2000@yahoo.co.in |
| Dr. Shrikant Pensalwar |
Balaji Clinic, Main Road, Devipada, Borivali (E) |
,-400066
Mumbai
MAHARASHTRA |
9892576630
dr.penshree@yahoo.co.in |
| Dr. B.S.V Prasad |
Behind Hotel Vasco, Nasik Road |
,-422101
|
9822039737
bsvprasad@rediffmail.com |
| Dr Ganesh Avhad |
INSTRIDE, 6 poonam arcade,1170/11 revenue colony, J.M Road Shivaji Nagar, |
,-411005
Pune
MAHARASHTRA |
9890590801
020-25530899
avhadganesh@yahoo.com |
| Dr Manoj Deshpande |
Pungaliya Hospital, opp veer savarkar bhavan, Shivaji Nagar |
,-411005
Pune
MAHARASHTRA |
9422010714
mnjdeshpane@yahoo.com |
| Dr Prakash Thombre |
Sector 27 A/150, Nigadi pradhikaran |
,-411044
Pune
MAHARASHTRA |
9850042832
prakashpillu@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| ISBEC Dr. B.S.V. Prasad |
Approved |
| ISBEC Dr. Ganesh Avhad |
Approved |
| ISBEC Dr. Manoj Chaudhari |
Approved |
| ISBEC Dr. Manoj Deshpande |
Approved |
| ISBEC Dr. Prakash Thombare |
Approved |
| ISBEC Dr. Shrikant Pensalwar |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Male Sexual Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
E-MA-H & E-MA-HP |
2 capsules twice a day with milk for 2 months |
| Comparator Agent |
Placebo (Starch) |
2 capsules twice a day for 2 months |
|
Inclusion Criteria
Modification(s)
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Males aged between 21-60 yrs
2. Subject having a monogamous, heterosexual relationship
3. Subject satisfying any one of the following criteria.
a. Subject having Erectile dysfunction IIEF A Score in between 11-21
b. Premature Ejaculation IPE Score in between 18-28
c. Other sexual dysfunction IIEF B Score in between 21-30
|
|
| ExclusionCriteria |
| Details |
1. Subjects taking herbal or Ayurvedic/Herbal treatment in the last 15 days (Only for Male Sexual Dysfunction).
2. Subjects taking any other treatment in the last 7 days (Only for Male Sexual Dysfunction).
3. Subjects with major psychiatric disorders or severe systemic disorders
4. History of stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia or spinal cord injury within the past 6 months.
5. Subject having uncontrolled diabetes mellitus and/or h/o diabetes mellitus for more than 10 years.
6. H/o Male Sexual Dysfunction more than six months in diabetic subjects.
7. Anatomical deformity of the penis such as severe penile fibrosis or Peyronie's disease or phimosis.
8. K/C/O HIV Positive and AIDS
9. Has an abnormal thyroid stimulating hormone (TSH) level lower than 30% of LLN or more than 30% of ULN.
10. Has erectile dysfunction caused by neurological or endocrine factors such as hyperprolactinemia or low serum testosterone levels (<200 ng/dl).
11. Has a history of drug abuse (alcohol, marijuana, cocaine, or opiates).
12. Is using medications that are known to cause sexual dysfunction (cimetidine, spironolactone, thiazides, adrenergic blockers, anti- depressants etc).
13. Subject has participated in any clinical trial within last 30 days.
14. Subjects not ready to sign the consent & unable to comply with the protocol.
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|
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Method of Generating Random Sequence
|
Stratified block randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) International Index for Erectile function(subscale A)
2) International Index for Erectile function(subscale B)
3)Index for Premature Ejaculation |
Screening (D-7/-15), Day 1, Day 7, Day 15, Day 30, Day 45 & Day 60. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) Total score of International Index for Erectile function (scoreA + scoreB)
2) Serum Testosterone
3) Erectile dysfunction inventory for treatment satisfaction questionnaire (male & female version).
4) Global assessment by the investigator. |
1) Screening (Day-7/Day-15), Day 1, Day 7, Day 15, Day 30, Day 45 & Day 60.
2) Screening (Day-7/Day-15), Day 30 & Day 60.
3) Day 30 & Day 60.
4) Day 60. |
|
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Target Sample Size
|
Total Sample Size="0"
Sample Size from India=""
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/01/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Triple blind, randomized, double dummy, prospective placebo controlled, dose determination study to investigate the safety and efficacy of E-MA-H and E-MA-HP capsules as dietary supplements for Male Sexual Health. About 156 males with Male Sexual Dysfunction (MSD) between 21-60 years of age will be enrolled in the study to get 120 completed subjects. Recruitment of subjects will be done through the investigator?s own direct contact or subject referral to the selected investigators.
For each subject, the study will terminate after a maximal period of 60 days from day 1. On Screening Visit (Visit I), a thorough explanation will be given to each patient on the aims and course of the study, as well as a full explanation on dosage, mode of administration, safety and efficacy of E-MA-H and E-MA-HP Capsules. After reading and signing an informed consent, Investigator/co-ordinator will administer each question from IIEF (International Index of Erectile Function)) and IPE (Index of Premature Ejaculation) questionnaires to the subject and response from the subject will be noted down. If subject is fulfilling the inclusion criteria with respect to IIEF and IPE scores then he will be sent for ECG, Blood & Urine examinations. If the subject satisfies the inclusion criteria, he will be randomized in the study. There will be 7 days period between screening and baseline visit which could be extended maximum up to 15 days, depending upon the medication the subject may be on at the time of screening. Subject will be asked to stop any medication that he might be taking for MSD. He will be put on 15 days wash-out period if he is taking Ayurvedic/Herbal medicine and on 7 days wash-out period if he is taking any other treatment for MSD. In case the investigations are not done in the preset time period & the record of the same will be maintained At baseline Day 1, physical examination will be performed. IIEF, IPE questionnaires will be filled. Intravaginal Ejaculatory Latency Time (IELT) will be also noted down in minutes. First follow-up visit will be after 7 days. The subsequent follow up visits will be at Day 15, Day 30, Day 45, and Day 60. For each visit subject will be provided with new IIEF (full version), IPE questionnaires. IELT will be also noted down in minutes. Each subject will receive another supply of the trial medications during these visits except at day 7 and day 60. On Day 30 and Day 60 EDITS questionnaire subject and partner version will be also taken.
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