| CTRI Number |
CTRI/2025/03/082805 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Back to Teens a Ayurvedic Medicine for sexual Dysfunction |
|
Scientific Title of Study
|
A Study on Role of Back to Teens an Ayurvedic Proprietary Medicine in the Management of Erectile Dysfunction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Biswajit Das |
| Designation |
Associate Professor |
| Affiliation |
Govt. Ayurvedic College, Jalukbari, Guwahati-14 Assam |
| Address |
Department of Clinical Toxicology, Room No. 18, Govt. Ayurvedic College, Jalukbari, Guwahti - 14, Assam
Kamrup
ASSAM
781014
India |
| Phone |
9127056217 |
| Fax |
|
| Email |
drbiswa.das@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Biswajit Das |
| Designation |
Associate Professor |
| Affiliation |
Govt. Ayurvedic College, Jalukbari, Guwahati-14 Assam |
| Address |
Department of Clinical Toxicology, Room No. 18, Govt. Ayurvedic College, Jalukbari, Guwahti - 14, Assam
Kamrup
ASSAM
781014
India |
| Phone |
9127056217 |
| Fax |
|
| Email |
drbiswa.das@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Biswajit Das |
| Designation |
Associate Professor |
| Affiliation |
Govt. Ayurvedic College, Jalukbari, Guwahati-14 Assam |
| Address |
Department of Clinical Toxicology, Room no. 18, Govt. Ayurvedic College, Jalukbari, Guwahti - 14, Assam
Kamrup
ASSAM
781014
India |
| Phone |
9127056217 |
| Fax |
|
| Email |
drbiswa.das@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| ZERO HARM Science Private Limited, Unit No. B 23, Phase 2 Technocrat, Cooperative Industrial Estate, Balanagar, Hyderabad, Telangana, Pin 500037, India |
|
|
Primary Sponsor
|
| Name |
ZERO HARM Science Private Limited |
| Address |
Unit No. B 23, Phase 2 Technocrat, Cooperative Industrial Estate, Balanagar, Hyderabad, Telangana, Pin 500037, India |
| Type of Sponsor |
Other [Pharmaceutical Company] |
|
|
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 Biswajit Das |
Govt. Ayurvedic College & Hospital |
Room No. 9, Govt. Ayurvedic College and Hospital, Jalukbari Guwahti Assam, Pin-
781014, India
Kamrup
ASSAM |
9127056217
drbiswa.das@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Govt Ayurvedic College Jalukbari Guwahati Assam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N469||Male infertility, unspecified. Ayurveda Condition: KLAIBYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Placebo | Sugar Pill (500mg once daily orally) | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Back to Teens, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 700(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Patients with Erectile Dysfunction |
|
| ExclusionCriteria |
| Details |
Patients with Diabetes Mellitus
immunocompromised Patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Able to enjoy healthy sexual life |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Able to enjoy Sexual Healthy life and able to treat infertility |
90 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/04/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
Modification(s)
|
The eligible patients of erectile dysfunction will be treated with Back to Teens an ayurvedic medicine for a duration of three months. Two follow ups will be carried out at the interval of 1 month. Before and After the treatment, laboratory investigations will be carried out to find out the improvements of the patients. |