| CTRI Number |
CTRI/2025/03/082805 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2026 |
| 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)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2025 |
| Date of Study Completion (India) |
21/05/2026 |
| 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)
|
Brief methodology: It is a randomized, Parallel Group, Open Label, Prospective, Interventional Clinical Study to evaluate the role of Zeroharm Sciences Back to Teens , an Ayurvedic Proprietary medicine, in the management of Erectile Dysfunction (Klaibyam). Results: All 50 enrolled participants completed the 90-day study . The cohort comprised 50 males with a mean age of 37.5 years (SD=7.2; SE=1.02), consistent with the reproductive-age and middle-aged male Indian population presenting with Erectile Dysfunction (Klaibyam). Zeroharm Sciences Back to Teens produced statistically highly significant improvements in both primary outcome measures in the intervention arm (N=25): IIEF-5 score increased from 12.4+/-4.2 to 18.6+/-3.7(mean improvement: +6.2 points; serum tolerance increased from 312.8+/-89.4 to 428.6+/-76.3 ng/dL (mean increase: +115.8 ng/dL). The placebo arm showed no statistically significant change in either outcome (IIEF-5: p=0.412; Testosterone: p=0.387). Symptomatic assessment revealed a two wave resolution pattern: generalized weakness/fatigue (Daurbalya) and loss of libido (Klaibya) resolved completely by Day 30; inability to achieve erection (Napumshakata) resolved or substantially improved by Day 90; body heaviness and reduced seminal volume (Shukra-alpatva) showed partial improvement, reflecting the longer biological timeline for full androgenic restoration. No adverse events (AE) or Serious Adverse Events (SAE) were observed in any participant in either arm throughout the 90-day study period. Conclusion: Ninety days of treatment with Zeroharm Sciences Back to Teens produces highly significant and clinically meaningful improvements in erectile function (IIEF-5 score: +50%) and serum testosterone (+37%) in males with Erectile Dysfunction (Klaibyam), with consistent age-independent efficacy across the 25-50 year age range and progressive resolution of classical Klaibyam Lakshanas. Zeroharm Sciences Back to Teens is exceptionally well-tolerated with a complete absence of adverse events across all 50 participants in both intervention and placebo arms. Zeroharm Sciences Back to Teens can be recommended as a safe, effective and well-tolerated Ayurvedic therapeutic option for the management of Erectile Dysfunction (Klaibyam). |