CTRI/2025/08/093353 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On:
24/12/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Ayurveda Nutraceutical
Study Design
Single Arm Study
Public Title of Study
This is Clinical Study to Evaluate the Efficacy and Safety of X-TendPower Capsule for Low Libido and/or Erectile Dysfunction in Patients with a History of Smoking, Early-Onset Type 2 Diabetes Mellitus, and Psychological Stress.
Scientific Title of Study
A Multicentric, Single-Arm Open-label Clinical Study to Evaluate the Efficacy and Safety of X-TendPower Capsule for Low Libido and/or Erectile Dysfunction in Patients with a History of Smoking, Early-Onset Type 2 Diabetes Mellitus, and Psychological Stress.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
IR-CT-ED-2025, Version 1.0 Dated 28-Jul-2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sandeep Kumar Gupta
Designation
Principal Investigator
Affiliation
MV Hospital and Research Centre
Address
Research Department
Room No. 7 to 10,
Ground Floor, Mirza Mandi, 314/32, Chowk, Lucknow, Uttar Pradesh 266024
Lucknow UTTAR PRADESH 266024 India
Phone
9336077839
Fax
Email
sandeepkumar.gupta@rediffmail.com
Details of Contact Person Scientific Query
Name
Dr Devesh Kumar
Designation
Founder and Managing Director
Affiliation
IR Innovate Research Pvt. Ltd.
Address
Building C-120, 3rd Floor, Sector - 2, Noida- 201301, Uttar Pradesh, India
Gautam Buddha Nagar UTTAR PRADESH 201301 India
Phone
9971169602
Fax
Email
devesh.kumar@innovate-research.com
Details of Contact Person Public Query
Name
Dr Devesh Kumar
Designation
Founder and Managing Director
Affiliation
IR Innovate Research Pvt. Ltd.
Address
Building C-120, 3rd Floor, Sector - 2, Noida- 201301, Uttar Pradesh, India
Gautam Buddha Nagar UTTAR PRADESH 201301 India
Phone
9971169602
Fax
Email
devesh.kumar@innovate-research.com
Source of Monetary or Material Support
Greenspace, Unit No. 0401N, 4th Floor, Beacon Tower-2, BRIGADE TWIN TOWERS, No. 11/1-4, Jai Bharath Industries Pipeline Road,Yeshwanthpur, Bengaluru-560 022
Primary Sponsor
Name
Greenspace
Address
Unit No. 0401N, 4th Floor, Beacon Tower-2, BRIGADE TWIN TOWERS, No. 11/1-4, Jai Bharath Industries Pipeline Road,Yeshwanthpur, Bengaluru-560 022
Type of Sponsor
Other [Nutraceutical ]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 2
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Sandeep Kumar Gupta
M V Hospital & Research Centre
Research Department
Room No. 7 to 10,
Ground Floor, Mirza Mandi, 314/32, Chowk, Lucknow, Uttar Pradesh 266024 Lucknow UTTAR PRADESH
9336077839
sandeepkumar.gupta@rediffmail.com
Dr Vineet Kumar Shukla
Tender Palm Super Speciality Hospital
Research Room, Amar Shaheed Path near Ekana International Cricket Stadium Road, Sector 7, Gomti Nagar, Lucknow, Uttar Pradesh 226001 Lucknow UTTAR PRADESH
7905304034
vineetshukla38@gmil.com
Details of Ethics Committee
No of Ethics Committees= 2
Name of Committee
Approval Status
Independent Ethics Committee Narayana Diagnostics
Approved
Inst. Ethics committee for MV Hospital and Research centre
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:F520||Hypoactive sexual desire disorder. Ayurveda Condition: NAPUMSAKASARPADASHTAH,
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Intervention Arm
Drug
Classical
(1) Medicine Name: Ashwagandha, Reference: Herb, Route: Oral, Dosage Form: Churna/ Powder, Dose: 00(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: The proposed clinical trial investigates a herbo-nutraceutical formulation containing traditional Ayurvedic
ingredients(2) Medicine Name: Guduchi, Reference: Herb, Route: Oral, Dosage Form: Churna/ Powder, Dose: 00(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: The proposed clinical trial investigates a herbo-nutraceutical formulation containing traditional Ayurvedic
ingredients(3) Medicine Name: Kaunch, Reference: Herb, Route: Oral, Dosage Form: Churna/ Powder, Dose: 00(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: The proposed clinical trial investigates a herbo-nutraceutical formulation containing traditional Ayurvedic
ingredients(4) Medicine Name: Mustaka, Reference: Herb, Route: Oral, Dosage Form: Churna/ Powder, Dose: 00(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: The proposed clinical trial investigates a herbo-nutraceutical formulation containing traditional Ayurvedic
ingredients(5) Medicine Name: Gokshura, Reference: Herb, Route: Oral, Dosage Form: Churna/ Powder, Dose: 00(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: The proposed clinical trial investigates a herbo-nutraceutical formulation containing traditional Ayurvedic
ingredients(6) Medicine Name: Shilajit, Reference: Herb, Route: Oral, Dosage Form: Churna/ Powder, Dose: 00(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: The proposed clinical trial investigates a herbo-nutraceutical formulation containing traditional Ayurvedic
ingredients
Inclusion Criteria
Age From
30.00 Year(s)
Age To
55.00 Year(s)
Gender
Male
Details
1. Male participants aged 30 to 55 years.
2. History of low libido and/or erectile dysfunction (diagnosed or self-reported, greater than or equal to 3 months), as defined by an International Index of Erectile Function (IIEF-15) score less than or equal to 21.
3. History of smoking (current or former smokers with at least 1–5 cigarettes per day).
4. Diagnosed with early-onset Type 2 Diabetes Mellitus (diagnosis before the age of 45, with current HbA1c between 6.5 percentage and 8.5 percentage) within the last 6 months.
5. Moderate to high perceived stress, defined by a score greater than or equal to 14 on the Perceived Stress Scale (PSS-10).
6. Willing and able to provide written informed consent.
7. Willing to comply with all study-related procedures and assessments for the full duration of the study.
8. Stable dose of ongoing medications for Chronic ailments (e.g., antidiabetic, antihypertensive) for the past 3 months
ExclusionCriteria
Details
1. Severe ED due to anatomical or neurological causes (e.g., spinal cord injury, post-prostatectomy).
2. Use of PDE-5 inhibitors or other ED medications in the past 4 weeks.
3. Uncontrolled T2DM (HbA1c greater than 8.5 percentage) or recently initiated antidiabetic therapy (within 3 months).
4. History of myocardial infarction, stroke, or unstable angina within the last 6 months.
5. Hypogonadism or androgen deficiency, defined by serum testosterone less than 200 ng/dL.
6. Psychiatric disorders (e.g., severe depression, psychosis) requiring medication.
7. Known hepatic or renal impairment (ALT or AST greater than 2.5× ULN, eGFR less than 60 mL/min).
8. Any active malignancy or treatment for cancer within the last 12 months.
9. Known allergy or hypersensitivity to any component of the supplement capsule.
10. Participation in another investigational study within the past 30 days
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Improvement in libido and/or erectile function assessed by the International Index of Erectile Function (IIEF-15) questionnaire.
From baseline to end of study (90 Days).
Secondary Outcome
Outcome
TimePoints
Changes in nitric oxide levels (pre- and post-intervention)
Changes in nitric oxide levels (pre- and post-intervention):
- Time Frame: Day -2 to -1, Day 90
Changes in serum TNF-alpha and IL-6 levels (inflammatory biomarkers)
Changes in inflammatory biomarkers:
- Interleukin-6 (IL-6) Changes.
- Tumor Necrosis Factor-alpha (TNF-alpha) Changes.
Time Frame: Day -2 to -1, Day 90
Changes in perceived stress levels assessed by the Perceived Stress Scale (PSS).
Changes in perceived stress levels assessed by the Perceived Stress Scale (PSS):
- PSS-10.
Time Frame: Day -2 to -1, Day 30 Day 90
Changes in serum testosterone levels (total and free)
Changes in serum testosterone levels (total and free):
Time Frame: Day -2 to -1, Day 90
Safety evaluated via adverse event monitoring and laboratory assessments
Safety Endpoints:
- Adverse Events: Incidence of treatment-emergent adverse events (TEAEs) will be monitored.
- SAEs: Identification and documentation of any serious adverse events that occur during the study, requiring immediate medical attention or hospitalization
- Vital Signs: Monitoring of participants’ vital signs (blood pressure, heart rate, respiratory rate, temperature) to assess any significant weight changes during the trial.
Time Frame: Day -2 to -1, Day 30, Day 90
Target Sample Size
Total Sample Size="120" Sample Size from India="120" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Erectile
dysfunction (ED) and low libido are prevalent sexual health disorders,
particularly in men exposed to metabolic and lifestyle risk factors such as chronic
smoking, early-onset type 2 diabetes mellitus (T2DM), and psychological
stress. These interconnected conditions contribute to vascular
dysfunction, hormonal imbalance, and neuroendocrine dysregulation,
leading to impaired erectile function and diminished sexual desire.
Modern
pharmacotherapies, such as PDE5 inhibitors, offer limited relief in these
populations, especially when psychological, hormonal, and metabolic pathways
are simultaneously compromised. This underlines the need for a multi-targeted,
holistic intervention that is effective, safe, and well-tolerated in
long-term use.
The
proposed clinical trial investigates a herbo-nutraceutical formulation
containing traditional Ayurvedic ingredients—Ashwagandha, Guduchi, Kaunch,
Mustaka, Gokshura, and Shilajit—all of which have shown promising evidence
in improving sexual function, stress resilience, endocrine modulation, and
metabolic support.