| CTRI Number |
CTRI/2025/11/096982 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| 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 if Vaji Amrit Vati is safe and improves sexual problems in men. |
|
Scientific Title of Study
|
An open-label, single-arm, single-center, Phase 3 clinical study to evaluate the safety and efficacy of Vaji Amrit Vati in subjects with Vajikara, Rasayan (Erectile Dysfunction). |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2524 Version No 1.0 Dated 06 Oct 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sambashiva |
| Designation |
Principal Investigator |
| Affiliation |
Samahitha Research Solutions |
| Address |
#301, Ground Floor, 3rd Main Road, Old Extension, KR Puram,
Bangalore
KARNATAKA
560036
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
drsambashiva.sl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi LM |
| Designation |
HOD-Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
09739001749 |
| 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
Bangalore
KARNATAKA
560069
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Kudos Laboratories India
Plot No. 12, Industrial Area,
Shoghi, Distt. Shimla - 171219(H.P.) |
|
|
Primary Sponsor
|
| Name |
Kudos Laboratories India |
| Address |
Plot No. 12, Industrial Area,
Shoghi, Distt. Shimla - 171219(H.P.) |
| 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 Sambashiva |
Sri Lakshmi Super Speciality Hospital |
#301, Ground Floor, 3rd Main Road, Old Extension, KR Puram,
Bangalore
KARNATAKA |
06364898825
drsambashiva.sl@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:N529||Male erectile dysfunction, unspecified. 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: Vaji Amrit Vati , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: All participants will receive VajiAmritVati (1 tablet twice daily after meals) for 14 consecutive days. |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1.Gender or Age- Male participants aged 25 to 65 years.
2.Diagnosis: Clinically established mild-to-moderate erectile dysfunction, confirmed by investigator assessment and an IIEF-15 total score between 11 and 25 (inclusive) at baseline.
3.Relationship Status: Living with or having a regular sexual partner willing to cooperate with study assessments.
4.Health Status:
o Medically stable, judged suitable for participation based on medical history and physical examination.
o Able and willing to abstain from any other sexual-enhancement medications or supplements during the study.
5.Consent: Capable of understanding study procedures and providing written informed consent prior to participation.
6.Compliance: Willing and able to comply with study requirements, including diary completion and visit attendance.
|
|
| ExclusionCriteria |
| Details |
1. Severe erectile dysfunction with IIEF score less than 10, showing complete inability to achieve or maintain an erection sufficient for penetration.
2. History of secondary sexual disorders such as premature ejaculation, decreased libido of psychogenic origin, or other diagnosed sexual disorders.
3. Presence of major medical conditions including:
4. Uncontrolled hypertension with blood pressure equal to or above 160 by 100 mmHg, diabetes mellitus with HbA1c more than 8.5, severe dyslipidemia, hepatic or renal impairment.
5. Recent myocardial infarction, stroke, or major cardiovascular event within the last six months.
6. Known endocrine or neurological disease affecting sexual function.
7. History of surgical or anatomical causes such as radical prostatectomy, pelvic surgery, or pelvic radiotherapy.
8. Use of drugs or substances that may interfere with study outcomes including:
9. Use of PDE5 inhibitors, testosterone therapy, or other erectile dysfunction drugs within two weeks prior to baseline.
10. Current use of antidepressants, antipsychotics, opioids, or other medications known to impair sexual function.
11. Current alcohol or substance abuse.
12. Known hypersensitivity or intolerance to any herbal, mineral, or excipient component of VajiAmritVati.
13. Participation in another clinical trial or exposure to any investigational product within 30 days prior to enrollment.
14. Serious psychiatric disorder or any condition that, in the investigator’s judgment, could interfere with subject compliance or data reliability.
15. Any other clinically significant laboratory or physical finding that may pose undue risk or interfere with study outcomes as judged by the investigator. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in International Index of Erectile Function (IIEF-15) total score from Baseline (Day 0) to End of Study (Day 14 ± 2 days). The IIEF-15 is a validated tool measuring erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. |
Day 0, Day 7 ± 2, Day 14 ± 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in Erection Hardness Scale (EHS) score from Baseline to Day 14 ± 2 days.
2. Changes in libido, frequency of sexual activity, sexual satisfaction, and stamina assessed via patient-reported outcome questionnaires at Day 0, Day 7 ± 2 days, and Day 14 ± 2 days.
3. Safety and tolerability assessed by monitoring adverse events, serious adverse events, and vital signs throughout the study period (Day 0 to Day 14 ± 2 days). |
Day 0, Day 7 ± 2 days, and Day 14 ± 2 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/11/2025 |
| Date of Study Completion (India) |
26/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="16" |
|
Recruitment Status of Trial (Global)
|
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
Modification(s)
|
This Phase III, open-label, single-arm, single-center clinical study aims to evaluate the safety and efficacy of VajiAmritVati in adult males with mild-to-moderate erectile dysfunction. The primary objective is to assess improvement in erectile function using the International Index of Erectile Function (IIEF-15) over 14 days of treatment. Secondary objectives include evaluation of erection hardness, libido, sexual activity frequency, satisfaction, stamina, and safety profile. The study will provide clinical evidence to support the traditional Ayurvedic use of VajiAmritVati and generate data necessary for future larger randomized controlled trials, contributing to the scientific validation and integration of Ayurvedic therapies in managing erectile dysfunction. Result A total of 30 subjects were enrolled in the study, of which 27 completed the 14-day treatment period. The study showed a significant improvement in erectile function, with IIEF-15 scores increasing across all domains, including erection frequency, rigidity, penetration ability, maintenance of erection, orgasmic function, sexual desire, and overall satisfaction. The Erection Hardness Scale improved from a mean of 1.36 at baseline to 3.06 at Day 14, indicating erections adequate for penetration. Patient-reported outcomes showed marked improvements in libido, stamina, frequency of sexual activity, arousal, and partner satisfaction. Both Investigator and Patient Global Impression of Change reflected clear improvement from baseline. Quality-of-life scores in psychological and sexual relationship domains also improved significantly. No serious adverse events were reported, and only mild, transient events occurred. Overall, Vaji Amrit Vati demonstrated strong efficacy and good tolerability within the 14-day treatment period. |