| CTRI Number |
CTRI/2019/06/019517 [Registered on: 04/06/2019] Trial Registered Prospectively |
| Last Modified On: |
03/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trial of PR/HC/1718/002 in patients suffering from sexual dysfunction. |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled study to evaluate efficacy and safety of PR/HC/1718/002 in patients suffering from sexual dysfunction. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PR/HC/1718/002 Ver 1.0 dated 10 Jan 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharad Dhawade |
| Designation |
Ayurvedic Consultant |
| Affiliation |
Lokmanya Medical Research Center |
| Address |
OPD 2, Floor 4, Lokmanya Medical Research Center, 314/B telco road, Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
|
| Fax |
|
| Email |
sharaddhawade123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Payal Gawali |
| Designation |
Manager |
| Affiliation |
Aayush Healthcare |
| Address |
Office no. D-117,Ground Floor, Jai Ganesh Vision, World of mother, Akurdi Pune 411035 Pune
Pune
MAHARASHTRA
411035
India |
| Phone |
|
| Fax |
|
| Email |
payalgawali.aayush@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Payal Gawali |
| Designation |
Manager |
| Affiliation |
Aayush Healthcare |
| Address |
Office No. D-117, Ground floor,Jai Ganesh Vision, World of mother, Akurdi Pune 411035 Pune
Pune
MAHARASHTRA
411035
India |
| Phone |
|
| Fax |
|
| Email |
payalgawali.aayush@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aayush Healthcare
Office No. D-117, Ground floor,Jai Ganesh Vision, World of mother, Akurdi Pune 411035 Pune |
|
|
Primary Sponsor
|
| Name |
Aayush Healthcare |
| Address |
D-117,Jai Ganesh Vision, World of mother, Akurdi Pune 411035 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Varsha Bachkar |
Lokmanya Medical Research Centre |
314/ B Telco Road, Chinchwad, Pune
Pune
MAHARASHTRA |
8446623333
bachkarvarsha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N529||Male erectile dysfunction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
2 capsules twice a day after meal with water for 3 months |
| Intervention |
PR/HC/1718/002 capsules |
2 capsules twice a day after meal with water for 3 months |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1.Male subjects aged 21-50 years suffering from ED.
2.Subjects who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit.
3.Subjects should be in an active stable sexual relationship for the entire duration of study
4.Subjects willing to participate in clinical trial and who have read understood and signed informed consent form.
5.Subjects willing to make all required study visits
|
|
| ExclusionCriteria |
| Details |
1.Subjects having anatomical abnormalities of the penis.
2.Patients that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs.
3.Subjects with severe form of sexual dysfunction as evidenced by at least one of the following conditions,
-An International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is less than 11 and greater than 25 at screening
-Subjects with prior ineffective treatment with (or non-responder to) any PDE5 Inhibitor or underwent treatment for promoting spermatogenic fertility in last 3 months
- Subjects with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease
-History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator
-Presence of any drug or therapy that may have relation with ED and sexual dysfunction (nitrates, anti-androgens, chemotherapy agents, radiotherapy, etc.)
4.Subjects with history or presence of significant alcoholism or drug abuse within the past 1 year.
5.Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion-
a.cardiovascular, b) cerebrovascular, c) dermatological, d) gastrointestinal, e) gynecological, f) hematological, g) hepatic, h) malignancy, i) metabolic, j) musculoskeletal, k) neurological, l) psychiatric, m) thyroid n) psychological, o) renal, p) respiratory, q) venereal, r) any other major disorders
6.Subjects with history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products more than 10 times per day.
7.Subjects with any clinically significant laboratory or ECG findings during screening.
8.Patients receiving hormonal treatment, antidepressants, antipsychotics, or any other psychoactive drugs.
9.Known cases of varicocele, hydrocele, HIV/AIDS, Hepatitis C and B, Cancer and major debilitating diseases
10.Known hypersensitivity to ingredients used in study drugs
11.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate efficacy of SHL 1046 in patients suffering from erectile dysfunction by assessing
1.Erectile function of penis on Erectile function subscale of IIEF Questionnaire
2.Sexual desire/ Libido (IIEF questionnaire)
|
Baseline, Day 30, Day 60, Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Hardness of penis
2.Subjective Vitality Score, Perceived Stress Scale,satisfaction with life score
3.Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire (Patient & Partner version)
4.Quality of Erection Questionnaire
5.Serum total testosterone
6.Sexual encounter profile as per the recordings in daily diary card, IELT
7.Drug compliance
8.Global assessment for overall improvement by the investigator and by patient at the end of the study treatment. |
Baseline, Day 30, Day 60, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/06/2019 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
PR/HC/1718/002 capsules will be assesed for efficacy and safety in male erectile dysfunction. |