| CTRI Number |
CTRI/2025/11/098051 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see how Vigorvolt tablet helps men with low sexual desire and low energy. |
|
Scientific Title of Study
|
A Prospective, Open-Label, Single-Arm, Single-Centre, Phase 3 Clinical Study
to Evaluate the Safety and Efficacy of Vigorvolt in Male Subjects with Low
Libido and Vitality |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2519 Version No. 1 Dated 10 Sep 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak M |
| Designation |
Principal Investigator |
| Affiliation |
Sri Lakshmi Super Speciality Hospital |
| Address |
Room No. 1, 5th floor clinical research room,
301, 3rd Main Rd, near Indane Gas, V B Layout, Old Extension, Krishnarajapuram
Bangalore
KARNATAKA
560036
India |
| Phone |
6364898825 |
| Fax |
|
| Email |
drdeepakm1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi L M |
| Designation |
HOD - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No. 1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block
Bangalore
KARNATAKA
560069
India |
| Phone |
9739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No. 1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block
Bangalore
KARNATAKA
560069
India |
| Phone |
6364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Vaidyarathnam Oushdhasala
Door No. 14/473/1, Thaikattussery, Ollur, Thrissur, Kerala - 680306, India |
|
|
Primary Sponsor
|
| Name |
Vaidyarathnam Oushadhasala |
| Address |
Door No. 14/473/1, Thaikkattussery, Ollur, Thrissur, Kerala - 680306, India |
| 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 |
| Dr Deepak M |
Sri Lakshmi Super Speciality Hospital |
Clinical Research Room,5th Floor, 301, 3rd Main Road, near Indane Gas, V B Layout, Old Extension, Krishnarajapuram
Bangalore
KARNATAKA |
6364898825
drdeepakm1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F520||Hypoactive sexual desire disorder. Ayurveda Condition: KLAIBYAM, (2) ICD-10 Condition:R538||Other malaise and fatigue. Ayurveda Condition: KLAIBYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Vigorvolt tablets, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Warm Water), Additional Information: -All eligible participants will receive the investigational product at a dose of 2 tablets twice daily (BID) before food with warm water for 60±3 days. |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
1. Male Participants aged 21 to 55 years at the time of consent.
2. Documented low serum total testosterone (less than or equal to 300 ng/dL), confirmed by a morning (08:00
10:00) sample at Screening.
3. Self-reported symptoms of low libido and vitality, including at least one of the following for greater than or equal to 3 months:
o Decreased sexual drive or reduced initiation of sexual activity.
o Difficulty in becoming sexually aroused.
o Fatigue and low energy levels.
4. Willingness to comply with the study protocol, including scheduled visits, treatment plan,
laboratory tests, and other procedures.
5. Able to provide written informed consent prior to initiation of any study-related procedures. |
|
| ExclusionCriteria |
| Details |
1. History of psychiatric illness (e.g., major depression, psychosis) or alcohol dependence.
2. Established or known organic pathology for sexual dysfunction (e.g., severe endocrinopathies,
untreated hypogonadism requiring TRT, significant prostatic disease).
3. Body Mass Index (BMI) greater than 37 kg/m² at Screening.
4. Severe lower urinary tract infection and/or clinically significant prostate enlargement (per
investigator’s judgment).
5. Current or recent (within 6 months prior to Screening) use of long-acting intramuscular
testosterone undecanoate or testosterone pellets.
6. Evidence of renal, hepatic, or cardiac failure.
7. Known HIV infection.
8. Participation in any other interventional clinical trial within the last 3 months.
9. Use of any other investigational drug within 1 month prior to randomization. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Vigorvolt in improving libido after 2 months of administration,
measured by changes in serum total testosterone levels from baseline to Day 60. |
Visit 1 Day -14 to -1
Visit 2 Day 0
Visit 3 Day 30 ±3 days
Visit 4 Day 60 ±3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the effect of Vigorvolt on sexual desire, measured by the Sexual Desire Inventory
(SDI).
2. To evaluate the effect of Vigorvolt on fatigue and vitality, assessed using the Fatigue
Severity Scale (FSS).
3. To assess the safety and tolerability of Vigorvolt by monitoring adverse events (AEs), vital
signs, physical examinations, and laboratory parameters (CBC and serum testosterone). |
Visit 1 Day -14 to -1
Visit 2 Day 0
Visit 3 Day 30 ±3 days
Visit 4 Day 60 ±3 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
06/12/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Brief Summary
This study will check how safe and effective Vigorvolt is in improving sexual desire and energy levels in men who have low libido and low vitality. A total of 30 men will take Vigorvolt for about 60 days, and the study will measure changes in testosterone levels, sexual desire, fatigue, and overall energy. Safety will also be monitored through regular check-ups and lab tests.
Purpose of the Study
The purpose of this study is to see whether Vigorvolt can naturally improve sexual desire, energy, and overall strength in men with low libido and low vitality, and to confirm that it is safe to use. |