| CTRI Number |
CTRI/2025/02/080342 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study on the Safety and Effectiveness of Shilajit resin in Enhancing Male Sexual Health |
Scientific Title of Study
Modification(s)
|
A randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of TruBlk TM Shilajit Resin in improving sexual health in males. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/054 Version No.: 3.00 Date: 25/03/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ninad Naik |
| Designation |
Principal Investigator |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
Room No 401 314
Fourth floor B Telco
Road Chinchwad
-
Pune
MAHARASHTRA
411033
India |
| Phone |
9637785567 |
| Fax |
- |
| Email |
drnaik2023@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Yadav |
| Designation |
Founder |
| Affiliation |
Amaara Ayurveda |
| Address |
Office No 64 Sector 6 IMT Manesar Gurgaon
-
South West
DELHI
122050
India |
| Phone |
9560891900 |
| Fax |
- |
| Email |
divya.yadav@amaarabotanicals.com |
|
Details of Contact Person
Public Query
|
| Name |
Amandeep Singh |
| Designation |
Founder and CEO |
| Affiliation |
Amaara Ayurveda |
| Address |
Office No 64 Sector 6 IMT Manesar Gurgaon
-
South West
DELHI
122050
India |
| Phone |
8769610100 |
| Fax |
- |
| Email |
amandeep.singh@amaarabotanicals.com |
|
|
Source of Monetary or Material Support
|
| Amaara Ayurveda
Plot No. 64, Sector-6, IMT Manesar, India Gurgaon 122050.
|
|
|
Primary Sponsor
|
| Name |
Amaara Ayurveda |
| Address |
Plot No 64 Sector 6 IMT Manesar Gurgaon |
| Type of Sponsor |
Other [Manufacturer and Exporter of Ayurvedic Extract ] |
|
|
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 Ninad Naik |
Lokmanya Medical Research Centre |
Fourth-floor OPD 401314 B Telco Road Chinchwad Pune
Pune
MAHARASHTRA |
9637785567
-
drnaik2023@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Medical Research Center |
Approved |
| Institutional Ethics Committee Lokmanya Medical Research Center |
Approved |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E291||Testicular hypofunction. Ayurveda Condition: OJAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Placebo | 250 mg placebo Resin twice daily with one cup (100-250 mL) of warm water on an empty stomach in the morning and at bedtime. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: TruBlkTM Shilajit Resin, Reference: NA, Route: Oral, Dosage Form: Arka, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: with one cup (100-
250 mL) of warm water on an empty stomach in the morning and at
bedtime. |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1)Male participants aged 35 to 50 years (both inclusive) with BMI not more than 30 kg/m2
2)Participants who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit
3)Participants with positive Saint Louis University Androgen Deficiency in Aging Males (ADAM) questionnaire indicative of testosterone deficiency at screening visit
4)Participants should be in an active stable sexual relationship (only married participants) for the entire duration of the study
5)Participants willing to participate in clinical trials and who have read understood and signed the informed consent form
|
|
| ExclusionCriteria |
| Details |
1)Previous events or other severe conditions that may affect sexual health or metabolic health
2)Participants with genital anatomical deformities, including but not limited to penile deformities
3)Participants for whom sexual activity is inadvisable because of their underlying disease status
4)Female partners experiencing sexual dysfunction such as painful intercourse low libido or other forms of sexual dysfunction as well as pregnant individuals
5)Participants with any significant comorbid condition or currently undergoing pharmacological treatment which in the investigators judgment may interfere with the clinical trial outcomes
6)Participants that have undergone radical prostatectomy spinal cord injury or any other surgery of urogenital organs
7)Participants with a history or presence of significant alcoholism or drug abuse within the past 1 year
8)Participants with a history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco or nicotine products more than 10 times per day
9)Any concomitant treatment that is not permissible including but not limited to nitrates anti-androgens chemotherapy agents radiotherapy etc
10)Recent participation in another clinical trial or receiving some other drug during the study besides that in the protocol
11)Known hypersensitivity to any of the ingredients of the investigational product
12)Participants concurrent use of sildenafil or other such drugs in the PDE5 inhibitor family energy supplements herbal or pharmaceutical aphrodisiacs body composition enhancing agents or other concurrent medication such as beta blockers contraceptives and psychotropic medications nutraceuticals or ayurvedic supplement for sexual health and well-being
13) Participants consuming any nutraceutical herbal or ayurvedic supplement for any other condition
14) Any other clinical condition in the investigator judgment finds the study participation unsuitable for the participant.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1) Changes in levels of total testosterone, free testosterone, cortisol, and nitric oxide
2) Changes in metabolic parameters like fasting blood sugar, fasting insulin and lipid profile
3) Changes in libido system score (LSS) score
4) Changes in the international index of erectile function (IIEF) (erectile and orgasmic functions, sexual desire, satisfaction with intercourse, and overall sexual satisfaction)
5) Changes in sexual stamina using intravaginal ejaculatory latency time (IVELT) score |
1)screening and day 90
2)screening and day 90.
3)screening day 30, day 60 and day 90
4)screening, day 30, day 60 and day 90
5)screening, day 30, day 60 and day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Changes in perceived stress scale (PSS) score
2)Changes in Fatigue Severity Scale (FSS) score
3)Changes in COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score
4)Changes in STAI (State-Trait Anxiety Inventory) score
5)Changes in Profile of Mood State (POMS) questionnaire score
6)Changes in Personal Assessment of Intimacy in Relationships (PAIR) (to be filled by partner) score
7)Changes in the gastrointestinal symptom rating scale (GSRS) score |
1)screening day 30 day 60 and day 90
2)screening day 30 day 60 and day 90
3)screening and day 90
4)screening and day 90
5)screening and day 90
6)screening and day 90
7)screening and day 90 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
Modification(s)
|
Sexual health significantly impacts the overall well-being and quality of life of middle-aged men. Factors such as declining testosterone levels, oxidative stress, and stress-related issues can lead to sexual dysfunction. Hypogonadism, affecting a substantial portion of the male population, particularly older men, impacts not only sexual function but also physical, mental, and emotional health. Decreased libido is a common concern influenced by factors such as age, mental well-being, and hormonal fluctuations. Cross-sectional studies have revealed an annual decline in morning total testosterone levels of 0.2-2% in men aged 40 and older. Furthermore, in elderly males, the coordinated release of LH and testosterone becomes desynchronized despite the maintenance of normal serum levels of these hormones. Results of previously conducted studies suggest that in middle-aged men, less pulsatile testosterone and more LH are secreted at night than in young men, with disruption of the association between testosterone rhythm and REM sleep. The decline in nocturnal testosterone secretion appears to involve a combination of testicular and pituitary hypogonadism. Sexual dysfunction can arise from imbalances in testosterone and thyroid hormone levels, necessitating a personalized management approach considering the underlying cause, severity, and associated health conditions. Nutraceutical supplements may offer potential support for maintaining healthy libido and overall well-being. Adverse health effects are a common concern with conventional therapies. Conversely, Ayurvedic supplementation may offer a complementary approach to conventional treatments for managing diseases by modulating biological processes such as inflammation, oxidative stress, and intracellular signaling. Research indicates that several medicinal plants may positively influence erectile function. Notably, the hypothalamus plays a critical role in converting testosterone to estradiol, a process that may be essential for testosterone’s impact on libido. Moreover, some herbal remedies have demonstrated the ability to elevate testosterone levels in men |