| CTRI Number |
CTRI/2021/04/032884 [Registered on: 16/04/2021] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Study on Amore-Female Sexual Wellness Drink of Sipwise Beverages in Sexual Wellness in Females. |
|
Scientific Title of Study
|
A Double Blind, Prospective, Randomized, Comparative, Placebo Controlled, Two Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of Amore-Female Sexual Wellness Drink of Sipwise Beverages Pvt. Ltd. in improving Sexual Wellness in Healthy Adult Female Subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/SDF/059/20 Version 03 23-Mar-21 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare Research and Development India Private Limited |
| Address |
Room no 1
Department of General Medicine
180-109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024.
Chennai
TAMIL NADU
600024
India |
| Phone |
04423720600 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare Research and Development India Private Limited |
| Address |
Room no 1
Department of General Medicine
180-109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024.
Chennai
TAMIL NADU
600024
India |
| Phone |
04423720600 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare Research and Development India Private Limited |
| Address |
Room no 1
Department of General Medicine
180-109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024..
Chennai
TAMIL NADU
600024
India |
| Phone |
04423720600 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| Sipwise Beverages Private Limited,
9 Cosmic Enclave, New Sama Road,
Sama, Vadodara-390008,
Gujarat, India.
|
|
|
Primary Sponsor
|
| Name |
Sipwise Beverages Private Limited |
| Address |
9 Cosmic Enclave, New Sama Road,
Sama, Vadodara-390008,
Gujarat, India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
180-109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VT Sriraam |
Raam Clinic |
Room no 1
Department of General Medicine
180-109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024.
Chennai
TAMIL NADU |
9840909155
md@auroushealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sexual Wellness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amore-Female Sexual Wellness Drink |
Dose- Two bottles (60ml each)
Dosage- Two bottles of Drink to be consumed per day, preferably chilled.
Treatment Duration-2 months-60 Days- per enrolled subject.
Route of Administration-Oral
|
| Comparator Agent |
Placebo Drink |
Dose- Two bottles (60ml each)
Dosage- Two bottles of Drink to be consumed per day, preferably chilled.
Treatment Duration-2 months-60 Days- per enrolled subject.
Route of Administration-Oral
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Healthy Adult Females between the ages of 21 and 65 -both ages inclusive- who are in a heterosexual, monogamous relationship with an active sexual life.
2. Subjects who have scored 38 to 57 -both scores inclusive- in the Female Sexual Function Index at the time of screening.
3. Heterosexual partner to be physically living with the subject.
4. Subjects willing to practice double barrier contraceptive methods throughout the study.
5. Subjects who are willing to abstain from use of herbal, allopathic or home remedies-oral or topical-for any sexual condition not limited to aphrodisiacs, achieving and maintenance of erection, improvement in sexual life etc.
6. Subjects phenotypically female at birth and with normal presentation of genitourinary and reproductive system that allows for a normal sexual life.
7. Subjects who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
8. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with known hypersensitivity to the ingredients of the investigational product.
2. Subjects with history or diagnosis of psychiatric disorders
3. Subjects with history of uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
4. Subjects with history of seizures.
5. Subjects on remission from cancer of any type less than 5 years at the time of screening.
6. Subjects who have participated in a clinical study less than 1 month before screening.
7. Any significant medical condition-e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc.-, any medical condition that is unstable or poorly controlled or other factor-e.g., planned relocation- that the Investigator felt would interfere with study evaluations and study participation.
8. Subjects who are planning a pregnancy and - or currently breastfeeding.
9. Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
10. Subjects who in the opinion of the Investigator or the Medical Experts are not eligible for enrolment in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Female Sexual Function Index-FSFI-: Improvement of greater than or equal to 20% from baseline in comparison with placebo.
2. Subject IP Feedback Questionnaire: Total Score of greater than or equal to 20 in comparison with Placebo.
|
1. Female Sexual Function Index-FSFI-: Day 1, Day 30, Day 60
2. Subject IP Feedback Questionnaire: Day 60
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/04/2021 |
| Date of Study Completion (India) |
30/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Design: A Double Blind, Prospective, Randomized, Comparative, Placebo Controlled, Two Arm Clinical Study. Indication: Female Sexual Dysfunction Investigational Product: Amore-Female Sexual Wellness Drink Comparator: Placebo Drink Dose or Dosage: Two bottles, two bottles of Drink to be consumed per day, preferably chilled. Subject Population: Healthy Adult Females between the ages of 21 and 65 years -both ages inclusive- who are in a heterosexual, monogamous relationship with an active sexual life. Number of Subjects: 40 Evaluable Subjects Treatment Arms: Two Treatment Arms Treatment arm I: 33 Subjects-Amore Female Sexual Wellness Drink Treatment arm II: 11 Subjects-Placebo Drink Assessments
1. Female Sexual Function Index-FSFI-: Day 1, Day 30, Day 60
2. Subject IP Feedback Questionnaire: Day 60 Background of the study: Female sexual dysfunction (FSD) is a common condition associated with physical and psychological factors. It is caused by failure in one or more biochemical pathways that are interlinked in a complex fashion; hence medicines that have a specific target molecule fail to address the issue. This lacuna with the existing limited drugs has created the necessity to identify more alternative medicines with reduced side effects, easy availability and affordability. Purpose of the Study Amore – Female Sexual Wellness Drink is made with herbs with known potential to have an effect in improving sexual wellness in adult Females. Hence this clinical study is done to evaluate the safety, effectiveness and tolerability of Amore- Female sexual wellness drink in improving the sexual wellness of healthy adult female subjects. |