| CTRI Number |
CTRI/2017/06/008791 [Registered on: 08/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
07/06/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on JPF-16 Capsules in Sexual Dysfunction in Females |
|
Scientific Title of Study
|
An open label, multi-center, prospective clinical study to Evaluation of Efficacy and Safety of JPF-16 Capsules in Sexual Dysfunction in Females |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JPF/SD/01/2016, Version 1. 0, 29th Apr. 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narendrakumar Bhanudas Mundhe |
| Designation |
Assistant Professor Departmental of Kayachikitsa |
| Affiliation |
KVTR Ayurvedic College and Hospital Boradi |
| Address |
OPD No 5 Ground Floor
KVTR Ayurvedic College and Hospital Boradi Taluka Shirpur Dist Dhule
Dhule
MAHARASHTRA
424428
India |
| Phone |
09850378206 |
| Fax |
|
| Email |
drnbmundhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
205 B Wing Blue Diamond Society Nayagoan Dahisar West Mumbai
Mumbai (Suburban)
MAHARASHTRA
400068
India |
| Phone |
9322522252 |
| Fax |
09322522252 |
| Email |
sanjaytamoli@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
205 B Wing Blue Diamond Society Nayagoan Dahisar West Mumbai
Mumbai (Suburban)
MAHARASHTRA
400068
India |
| Phone |
9322522252 |
| Fax |
09322522252 |
| Email |
sanjaytamoli@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Chatarubhuj Pharmaceutical Co.
Plot no. 77 Sector 6-A, II-E, SIDCUL, Ranipur Haridwar 249403 Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Chatarubhuj Pharmaceutical Co |
| Address |
Plot no. 77 Sector 6-A, II-E, SIDCUL,Haridwar. Uttarakhand
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Narendrakumar Bhanudas Mundhe |
KVTR Ayurvedic College Boradi |
OPD No 5 Ground Floor
KVTR Ayurvedic College and Hospital Boradi Taluka Shirpur Dist Dhule
Dhule
MAHARASHTRA |
09850378206
drnbmundhe@gmail.com |
| Dr Sachin Agiwal |
Shri Gurudeo Ayurved College and Hospital Amravati |
OPD No 28 Department of Swasthrakshan Akhil Bharatiya Shri Gurudeo Sevamandal Shri Gurudeo Ayurved College and Hospital Gurukunj Ashram Tal Tiosa Dist Amravati
Amravati
MAHARASHTRA |
9421829197
sachin.agiwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Akhil Bharatiya Shri Gurudeo Sevamandal, Shri Gurudeo Ayurved College, Gurukunj Amravati |
Approved |
| KVTR Ayurvedic College, Boradi, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Female Sexual Dysfunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
JPF-16 Capsule |
JPF-16 Capsule contains Kapikacchu, Ashvagandha, Keshar, Akarkara, Shvet Musali, Shilajit, Ashok, Lodhra, Pradrantak loha, Puspadhanwa ras and others
Dosage and Treatment Duration: 2 capsules twice a day after meals for a period of 4 weeks.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Diagnosis of Female Sexual Interest/Arousal Disorder according to the DSM-5 criteria (2013)
2. Be involved in a stable relationship and have a partner
3. Healthy according to normal results of medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant
|
|
| ExclusionCriteria |
| Details |
1.Subjects with major illnesses and sexual dysfunction due to anatomical, surgical or pharmacological causes
2.Subjects with history of major psychiatric disorder
3.Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery
4.Subjects with hypotension or uncontrolled hypertension, uncontrolled diabetes, hepatic impairment, renal impairment or hematological disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in sexual feelings and responses [assessment using Female Sexual Function Index (FSFI)]
|
Day -7, Day 0, Day 14 and Day 28
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Global assessment for overall improvement by the patient at the end of the study treatment.
2. Global assessment for overall improvement by the investigator at the end of the study treatment.
3. Assessment of Tolerability of study drug by assessing ADRs on study completion.
4. Assessment of Laboratory parameters |
Day -7, Day 0, Day 14 and Day 28
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It
is an open label, interventional, multi-center, prospective clinical study to
evaluate efficacy and safety of ‘JPF-16 Capsule’ in 38 female patients
suffering from sexual dysfunction. The study will be conducted at two sites in
India. The dose of the drug would be 2 capsules two times daily orally after
meals for 4 weeks. The primary outcome measures will be to assess efficacy of ‘JPF-16
Capsule’ on sexual feelings and responses [assessment using Female Sexual Function
Index (FSFI)] on day -7, day 0, day, 14 and day 28. The secondary outcomes will
be assessment of Global assessment for overall improvement by the investigator
and by the patient at the end of the study treatment, assessment of
tolerability of study drug by assessing adverse events and assessment of
laboratory parameters on day -7, day 0, day 14 and day 28 |