| CTRI Number |
CTRI/2010/091/002919 [Registered on: 17/02/2011] |
| Last Modified On: |
05/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
An exploratory, double blind, randomized, parallel group, placebo controlled, multicentric study to evaluate the efficacy and safety of ProvestraTM in female sexual dysfunction (FSD). |
|
Scientific Title of Study
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An exploratory, double blind, randomized, parallel group, placebo controlled, multicentric study to evaluate the efficacy and safety of ProvestraTM in female sexual dysfunction (FSD). |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
Not Applicable
N/A
India |
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Aliya shakeel |
| Designation |
|
| Affiliation |
|
| Address |
117, Morya House
Andheri (West)
Mumbai
MAHARASHTRA
400053
India |
| Phone |
022-42025703 |
| Fax |
022-66941179 |
| Email |
medical@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms. Sakshi Pawar |
| Designation |
|
| Affiliation |
|
| Address |
117, Morya House
Andheri (West)
Mumbai
MAHARASHTRA
400053
India |
| Phone |
022-42025703 |
| Fax |
022-66941179 |
| Email |
sakshi.p@vediclifesciences.com |
|
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Source of Monetary or Material Support
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|
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Primary Sponsor
|
| Name |
Leading Edge Marketing
PO Box CR-56766, Suite 1210
Nassau Bahamas
|
| Address |
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| Type of Sponsor |
|
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
|
Sites of Study
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| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Manoj Chaudhari |
169, Parvarti Gaon, |
Bhagirathi Medical Foundation,- 411009
Pune
MAHARASHTRA |
|
| Dr. Prakash Thombare |
Aditya Yog, Ayurvedic Prathistan, 6 - P 127 |
Shambhaji Nagar,Chinchwad-
Pune
MAHARASHTRA |
|
| Dr.Shrikant Pensalwar |
Balaji Clinic |
Main Devipada Road ,Borivali(East),--400066
Mumbai
MAHARASHTRA |
|
| Dr. Umesh Nagapurkar |
Dr. Nagapurkar?s Clinic, Sharanpur road |
Opp , Rajiv Gandhi Bhavan,Behind Raymond showroom,-422002.
|
9823146088
|
| Dr. Archana Avhad |
Flat no 3 ? C, 1st floor, ? Ashwini Heights?, Near Grahak Peth, |
Tilak road,Sadashiv Peth,-30
Pune
MAHARASHTRA |
9623452970
|
| Dr. Ashok Mulgaonkar |
Mangirish?, Ramkunwar Thakur Road, |
Near Movie GEM, ,Dahisar (East), -400068
Mumbai
MAHARASHTRA |
28282010 /2016
-
- |
| Dr. Nivedita Pawar |
Nivedita Hospital, Rohini Apt, |
Behind Saraswat Co-op Bank,,Canada Corner- 422002
|
0253 - 2572852
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Meet Ec Administrative/Corporate Address:Maher Nursing Home, G1-2/A Shri Krishna Avenue, Shri Krishna Nagar,Borivali East, Sawar Pada Corner, Mumbai 400 066 |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Sexual Dysfunction, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
One Tablet once in a day for 60 days |
| Intervention |
Provestra TM |
One Tablet Once in a day preferably with meals for 84 Days |
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Inclusion Criteria
Modification(s)
|
| Age From |
21.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Sexually active female aged between 21-55 yrs, in a stable monogamous relationship with a male partner for at least 6 months and who has been involved in sexual intercourse over the last four weeks
Females who have mixed desire / arousal /orgasm disorder and are distressed due to it since at least 3 months
Females with a baseline FSFI score of ≤ 20 and/or a domain score of <3 in at least 1 domain
Willing to attempt sexual activity at least twice a week during the study period.
|
|
| ExclusionCriteria |
| Details |
Women whose sexual dysfunction is limited to certain types of stimulation, situation or specific partners.
BMI > 40 kg/m2
Evidence of unresolved sexual trauma or abuse.
Primary anorgasmia, vaginismus, sexual pain disorder, sexual aversion disorder, or persistent sexual arousal disorder.
? Female sexual dysfunction caused by untreated endocrine disease, e.g., hypopituitarism, hypothyroidism, diabetes mellitus; Hyperprolactinemia
Chronic or complicated urinary tract or vaginal infections within previous 12 months (as determined by history).
Pelvic inflammatory disease within previous 12 months.
Currently active sexually transmitted disease.
Chronic dyspareunia not attributable to vaginal dryness within previous 12 months.
Currently active moderate to severe vaginitis.
Cervical dysplasia within previous 12 months.
Significant cervicitis as manifested by mucopurulent discharge from the cervix.
Significant gynecologic conditions such as uterine fibroids, vulvar vestibulitis, or vaginismus that may (in the investigator?s opinion) interfere with the subject?s ability to comply with study procedures.
Psychoses, bipolar and anxiety disorders.
History or evidence of significant cardiac, renal or hepatic disease within previous 6 months.
Significant central nervous system diseases within the last 6 months, i.e., stroke, spinal cord injury, multiple sclerosis, etc
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Method of Generating Random Sequence
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Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Female sexual Function Index (FSFI) domain scores and total score |
Change in FSFI scores as compared to baseline values |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of ProvestraTM in females suffering with FSD. |
? Grade assigned by investigator to the investigational product as good, fair or
poor.
? Subject opinion on willingness to continue the treatment
? Change in values of safety variables as compared to baseline values
? Tolerability to the investigational product.
|
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Target Sample Size
Modification(s)
|
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 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/01/2011 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
|
Publication Details
Modification(s)
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
An exploratory randomized, double blind, parallel group, placebo controlled multi-centric study to evaluate the efficacy and safety of the IP - ProvestraTM in female sexual dysfunction (FSD).
Sr. no.
ACTIVE INGREDIENT/ EXCIPIENTS Per Tablet in mg
ACTIVE INGREDIENT
1) Korean Ginseng root 16
2 Black cohosh root 25
3 Ginger root 25
4 Gingko biloba leaf 25
5 Red raspberry fruit 25
6 Valerian root 25
7 Damiana leaf 25
8 Licorice root 25
9 Kudzu root 25
10 Theobromine Cacoa seed 50
11 L ? arginine (base) 300
12 Indole 3 carbino 35
13 Vitamin A (Palmitate) 2
14 Vitamin B1 200 mcg
15 Vitamin B2 200 mcg
16 Vitamin B3 3
17 Vitamin B6 435 mcg
18 Vitamin B 12 12 mcg
19 Pantothenic Acid 2
20 Biotin 500 mcg
21 Folic acid (Folate) 800 mcg
2 Vitamin C (Ascorbic) 10
23 Vitamin E (Alpha tocopherol succinate) 5
24 Calcium carbonate 38
25 Iron (as Ferrous gluconate) 12
26 Zinc (as zinc gluconate) 9
EXCIPIENTS
1 Dicalcium Phosphate
2 Microcrystalline cellulose
3 Croscarmellose Sodium
4 Magnesium stearate
5 Hypromellose
6 Titanium dioxide
7 Propylene glycol
8 FD&C blue #1 lake
9 FD&C red # 3
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