| CTRI Number |
CTRI/2026/04/108451 [Registered on: 15/04/2026] Trial Registered Prospectively |
| Last Modified On: |
29/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [ Ayurvedic polyherbal formulation designed to improve erectile function.] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Check the Safety and Benefits of Tatkal Capsules in Adult Men with Erectile Dysfunction. |
|
Scientific Title of Study
|
AN OPEN-LABEL, SINGLE-ARM, SINGLE-CENTRE CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TATKAL CAPSULES IN TREATING ERECTILE DYSFUNCTION |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2536 Version 1 dated 02 Dec 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B N Satish |
| Designation |
Principal Investigator |
| Affiliation |
Upadhyaya Ayurveda Bhandara |
| Address |
Upadhyaya Ayurveda Bhandara
Near Srirampura Metro station, No.38 MMK road, Opp. to Devaiah Park, Bangalore-560021
Bangalore
KARNATAKA
560021
India |
| Phone |
7892914197 |
| Fax |
|
| Email |
drbnsatish@yahoo.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
560069
India |
| Phone |
09739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Mamatha B Gokavi |
| Designation |
Project Manager |
| 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 |
mamatha@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Renovision Exports Pvt. Ltd, 3rd Floor, REPL PLAZA,
Federal Colony, Phulwarisharif,
Patna-801505, Bihar |
|
|
Primary Sponsor
|
| Name |
Renovision Exports Pvt. Ltd |
| Address |
3rd Floor, REPL PLAZA,
Federal Colony, Phulwarisharif,
Patna-801505, Bihar |
| 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 B N Satish |
Upadhyaya Ayurveda Bhandara |
Upadhyaya Ayurveda Bhandara Room No.2,4th floor Clinical research Room,No 38, MKK road, Srirampura,Bangalore
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
07892114197
drbnsatish@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: Tatkal Capsule, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
-Male subjects aged twenty five to sixty years.
-Subjects who are willing and able to provide written informed consent before starting any study related procedures.
-Subjects with a confirmed diagnosis of erectile dysfunction for more than six months and less than five years.
-Subjects having a baseline International Index of Erectile Function erectile function score between eleven and twenty five, indicating mild to moderate erectile dysfunction.
-Subjects who are in a stable relationship for at least three months before screening and have a history of at least two sexual attempts per month for at least one month prior to enrollment.
-Subjects who are willing to follow all study procedures, attend scheduled visits, take the study medication as instructed, and complete the study diary.
-Subjects who are generally healthy, with no major active infections or clinically significant medical conditions, as assessed by the investigator. |
|
| ExclusionCriteria |
| Details |
-Subjects with known hypogonadism or structural abnormalities of the penis, including severe penile fibrosis.
-Subjects with a history of significant heart related diseases such as congestive heart failure, life threatening irregular heart rhythm, or ischemic heart disease.
-Subjects with an ongoing history of alcohol abuse or drug abuse.
-Subjects with neuromuscular disorders that affect sexual function.
-Subjects diagnosed with secondary hypertension.
-Subjects having severe complications of diabetes such as heart disease, kidney disease, or foot ulcer.
-Subjects who have participated in another clinical trial within the last thirty days prior to enrollment.
-Subjects with known allergy or hypersensitivity to any of the ingredients of Tatkal Capsules.
-Subjects who are unwilling or unable to provide written informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - Mean change from Baseline (Day 0) to End-of-Study (Day 30 ± 2 days) in the International Index of Erectile Function (IIEF) total score. The IIEF is a validated, multidimensional instrument measuring erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. |
- Baseline (Day 0)
- End of Study (Day 30± 2 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Change in EHS score Day 0 Day 30 2
-Change in Vigor Vitality Score VVQ6 Day 0 Day 30 2
-Patient Reported Outcomes libido frequency satisfaction stamina and improvement in sexual performance
-Safety parameters AEs ADRs incidence vitals |
- Baseline (Day 0)
- End of Study (Day 30± 2 days) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/04/2026 |
| 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="0"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
Purpose of the Study The purpose of this study is to evaluate the safety and effectiveness of the investigational Ayurvedic proprietary formulation in adult male participants with erectile dysfunction. The study aims to assess changes in erectile function–related parameters and overall sexual health during the treatment period, while monitoring tolerability, compliance, and adverse events, in order to generate clinical evidence under controlled conditions. |