| CTRI Number |
CTRI/2024/10/075403 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of the safety and efficacy of Over The Moon for the improvement of sexual health and wellness in men. |
|
Scientific Title of Study
|
A Randomized, Double-blind, Placebo-controlled, Single-centric Clinical Study to evaluate the safety and efficacy of Over The Moon for the improvement of sexual health and wellness in men. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No. : EQ/OTM/01 Version: 1.0 Dated:24/07/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Debadarshi Rath |
| Designation |
Senior consultant Urology |
| Affiliation |
UNCE( Uronephro Center of Excellence) |
| Address |
UNCE( Uronephro Center of Excellence) Plot 457/11713 Shree Vihar Patia Rd Infront of IOCL Office Chandrasekharpur Bhubaneswar Odisha 751024
Khordha
ORISSA
751024
India |
| Phone |
6370588163 |
| Fax |
|
| Email |
rathdebadarshi@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debadarshi Rath |
| Designation |
Senior consultant Urology |
| Affiliation |
UNCE( Uronephro Center of Excellence) |
| Address |
UNCE( Uronephro Center of Excellence) Plot 457/11713 Shree Vihar Patia Rd Infront of IOCL Office Chandrasekharpur Bhubaneswar Odisha 751024
ORISSA
751024
India |
| Phone |
6370588163 |
| Fax |
|
| Email |
rathdebadarshi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumya Ranjan Dey |
| Designation |
Project Manager |
| Affiliation |
Indivirtus Global CRO Pvt.Ltd. |
| Address |
Indivirtus Global CRO Pvt.Ltd.
521-522 Top Floor Taj Plaza Sector 118 Mohali Punjab India
Chandigarh
CHANDIGARH
160059
India |
| Phone |
7978306188 |
| Fax |
|
| Email |
ctprojects@indivirtus.com |
|
|
Source of Monetary or Material Support
|
| UNCE,Plot 457/11713, Shree Vihar, Patia Rd, Infront of IOCL Office, Chandrasekharpur, Bhubaneswar, Odisha 751024 |
|
|
Primary Sponsor
|
| Name |
Ethniq Ayush Exports LLP |
| Address |
3rd floor, Finvasia Centre,
D 179, Industrial Area, Sector 74,Sahibzada Ajit Singh Nagar, Punjab 160055
|
| 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 |
| DrDebadarshi Rath |
UNCE (Uronephro Center Of Excellence) |
UNCE( Uronephro Center of Excellence) Plot 457/11713 Shree Vihar Patia Rd Infront of IOCL Office Chandrasekharpur Bhubaneswar Odisha 751024
Khordha
ORISSA |
06370588163
rathdebadarshi@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIDS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Men sexual wellness |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Over The Moon, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: NA |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Age and Sex Male participants aged 25 to 65 years.
Sexual Health Concerns Self-reported issues with sexual health, such as reduced libido, erectile dysfunction, or general dissatisfaction with sexual performance, for at least three months prior to enrollment.
Health Status Generally healthy individuals with no significant uncontrolled chronic medical conditions (e.g., cardiovascular disease, diabetes mellitus, liver or kidney disease).
Participants must have a Body Mass Index (BMI) between 18.5 and 30 kg/m².
Sexual Activity Participants must be sexually active, defined as engaging in sexual activity at least once a month over the past three months.
Consent Willing and able to provide written informed consent to participate in the study.
Willing to comply with all study procedures, including taking the supplement and attending follow-up visits.
Medication and Supplement Use: Participants must agree to refrain from using other sexual health supplements or medications (such as PDE5 inhibitors like sildenafil) for the duration of the study.
Stable use of other medications for chronic conditions (e.g., antihypertensives) is allowed, provided these do not interfere with sexual function (except corticoids, diuretics, methyldopa, clonidine, guanethidine, and β blockers; especially those that are nonselective)
Baseline Laboratory Parameters: Baseline laboratory tests within normal limits or not clinically significant as determined by the investigator.
Normal baseline testosterone levels or those within the reference range for the laboratory used.
Lifestyle Factors: Non-smokers or light smokers (defined as smoking fewer than 10 cigarettes per day).
Moderate alcohol consumption, defined as up to two standard drinks per day.
Psychological Health No history of major psychiatric disorders such as severe depression, bipolar disorder, or schizophrenia.
No current use of antidepressants, antipsychotics, or other psychotropic medications that may affect sexual function.
Reproductive Status Participants must not be currently trying to conceive with their partner, or if they are, they must agree to use reliable contraception methods during the study period.
|
|
| ExclusionCriteria |
| Details |
Health Status Significant uncontrolled chronic medical conditions such as severe cardiovascular disease, uncontrolled diabetes mellitus, severe liver or kidney disease, or any other condition that, in the investigators opinion, would compromise the participants safety or the study integrity. History of significant gastrointestinal disorders e.g., Crohns disease, ulcerative colitis that may affect the absorption of the supplement. Sexual Health Treatments Current use of medications or therapies specifically for sexual dysfunction e.g., PDE5 inhibitors like sildenafil, tadalafil, testosterone replacement therapy, or other hormone treatments within the past three months. Use of other sexual health supplements or herbal products within the past three months. Medication Use Current use of medications that could interfere with sexual function, including certain antihypertensives e.g., beta-blockers, antidepressants e.g., selective serotonin reuptake inhibitors, antipsychotics, and other psychotropic drugs. Any investigational drug use within the past three months. Lifestyle Factors Heavy smokers. Excessive alcohol consumption, defined as more than two standard drinks per day. Current or recent history within the past year of substance abuse including drugs and alcohol. Psychological and Cognitive Health History of major psychiatric disorders such as severe depression, bipolar disorder, schizophrenia, or any other condition that, in the investigators opinion, would interfere with the participants ability to comply with the study requirements. Current use of psychotropic medications that may affect sexual function. Allergies and Sensitivities Known allergy or sensitivity to any ingredient in the supplement formulation. Reproductive Status Men who are actively trying to conceive with their partner or are not willing to use reliable contraception methods during the study period. Men with partners who are currently pregnant or breastfeeding. Participation in Other Studies Participation in another clinical trial within the past three months. Concurrent participation in another clinical trial that could interfere with this study outcomes. Compliance and Consent Inability or unwillingness to provide written informed consent. Inability or unwillingness to comply with all study procedures and attend follow-up visits. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Erectile Function by (IIEF-5) questionnaire
Increase in Libido by (SDI-2) questionnaire
Changes in Testosterone levels
|
60 days from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Overall Sexual Satisfaction by SSQ
Quality of Life Related to Sexual Health by Q-LES-Q
It will also include the incidence of treatment-emergent adverse events and serious adverse events, as well as changes from baseline in clinical laboratory tests, vital signs, physical examinations and other parameters if any.
|
60 days from baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/10/2024 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study’s goal is to assess Over The Moon’s safety and effectiveness in enhancing men’s sexual wellness and health.This Phase III clinical study will be double-blind, randomized, placebo-controlled, and single-centric. The targeted population will be split into two groups for the study: twenty participants in the active treatment group and twenty participants in the placebo group will receive the same treatment.
|