| CTRI Number |
CTRI/2024/12/078369 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial of Aswagandha and Shilajit in male sexual dysfunction due to mild to moderate stress disorders |
|
Scientific Title of Study
|
A double blind, randomized, placebo controlled clinical trial of Aswagandha (Withania somnifera) and Shilajit in male sexual dysfunction with special reference to erectile dysfunction and premature ejaculation due to mild to moderate stress disorders |
| 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 Tuhin Kanti Biswas |
| Designation |
Professor |
| Affiliation |
Raghunath Ayurved Mahavidyalaya and Hospital |
| Address |
Raghunath Ayurveda Mahavidyalaya and Hospital Raghunath Sarani, Contai, District-Purba Medinipur, West Bengal, PIN 721401
Medinipur
WEST BENGAL
721401
India |
| Phone |
9433173272 |
| Fax |
|
| Email |
jbrtkbiswas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tuhin Kanti Biswas |
| Designation |
Professor |
| Affiliation |
Raghunath Ayurved Mahavidyalaya and Hospital |
| Address |
Raghunath Ayurveda Mahavidyalaya and Hospital Raghunath Sarani, Contai, District-Purba Medinipur, West Bengal, PIN 721401
Medinipur
WEST BENGAL
721401
India |
| Phone |
9433173272 |
| Fax |
|
| Email |
jbrtkbiswas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tuhin Kanti Biswas |
| Designation |
Professor |
| Affiliation |
Raghunath Ayurved Mahavidyalaya and Hospital |
| Address |
Raghunath Ayurveda Mahavidyalaya and Hospital Raghunath Sarani, Contai, District-Purba Medinipur, West Bengal, PIN 721401
Medinipur
WEST BENGAL
721401
India |
| Phone |
9433173272 |
| Fax |
|
| Email |
jbrtkbiswas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sakti Naturals Pvt. Ltd
20 Mariyammankoll Street, Perambai, Villianur Taluk Villupuram District, Tamil Nadu 605110 |
|
|
Primary Sponsor
|
| Name |
Sakti Naturals Pvt. Ltd |
| Address |
20 Mariyammankoll Street, Perambai, Villianur Taluk Villupuram District, Tamil Nadu 605110
|
| 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 Tuhin Kanti Biswas |
Raghunath Ayurved Mahavidyalaya and Hospital |
Research Wing, Department of Kayachikitsa, Academic Building, 2nd Floor, Raghunath Ayurveda Mahavidyalaya and Hospital Raghunath Sarani, Contai, District-Purba Medinipur, West Bengal, PIN 721401
Medinipur
WEST BENGAL |
9433173272
jbrtkbiswas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Raghunath Ayurved Mahavidyalaya and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F451||Undifferentiated somatoform disorder. 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: Aswagandha, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Shilajit, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | | - | Placebo | Rice powder 500 mg OD before dinner |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
(a) male, age 25-60 years, (b) Predominant complain of sexual disorders with special emphasis on ED & PME (c) Associate complaint is anxiety, depression, or sleep disturbances related to chronic stress (d) Patient fulfill most of the criteria of DHS, PEDT, EHS, IIEF-5, PSS, HAM-A and HAM-D |
|
| ExclusionCriteria |
| Details |
(a) Anticipation of any change in stressors or life events, (b) Any clinically significant medical or psychiatric symptoms, (c) Patient already received any kind of aphrodisiac drugs, (d) Presence of unstable major medical comorbidity such as diabetes, hypertension, ischemic heart disease, and neuropsychiatric disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
i) To detect male sexual disorders and its specificity due to stress
ii) To determine efficacy of the root extracts of Aswagandha (W. somnifera) and Shilajit for male sexual disorders with special emphasis on erectile dysfunction (ED) and pre-mature ejaculation (PME)
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i) To determine safety aspect of the root extracts of Aswagandha (W. somnifera) and Shilajit
ii) To determine efficacy of the root extracts of Aswagandha (W. somnifera) and Shilajit with special emphasis on the level of serum cortisol, testosterone, FSH and LH
iii) To determine sexual dysfunction in male patient and determination of efficacy of the root extracts of Aswagandha (W. somnifera) and Shilajit on the basis of Dhat Syndrome Questionnaire (DHS), Premature Ejaculation Diagnostic Tools (PEDT), Erection Hardness Scale (EHS), Sexual Desire and Aversion (DESEA), IIEF-5, Perceived Stress Scale (PSS), Hamilton’s Anxiety Scale (HAM-A) and Hamilton’s Depression Scale (HAM-D)
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 |
|
Date of First Enrollment (India)
|
02/01/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The objective of the study will be to determine efficacy of the root extracts of Aswagandha (W. somnifera) and Shilajit for male sexual disorders with special emphasis on erectile dysfunction (ED) and pre-mature ejaculation (PME). This is an 8-week randomized, double-blind, placebo-controlled trial to compare the effectiveness of therapies. The primary inclusion criteria are males aged 25 to 60 who are major complainers of sexual disorders, with emphasis on ED and PME, and who also complain of anxiety, depression, or sleep abnormalities caused by chronic stress. 90 subjects will be randomized into the following 3 groups: (a) Aswagandha 500 mg/day, (b) Shilajit 250 mg/day, and (c) Placebo (inert) 500 mg/day. All test medicines will be taken before dinner for 8 weeks. After enrollment, the follow-up visits will be at 4 weeks and 8 weeks. There will be an additional follow-up at 9 weeks to assess treatment discontinuation symptoms, if any. Clinical efficacy will be assessed using the following instruments at screening (Day 0) and final visit (8 weeks): (a) PEDT, (b) EHS, (c) IIEF-5, (d) PSS, (e) HAM-A, (f) HAM-D, and (g) DESEA. Biochemical efficacy will be assessed at the same interval through (a) serum cortisol, (b) serum testosterone, and (c) serum LH and FSH levels. Clinical tolerability will be assessed using the Systematic Assessment for Treatment Emergent Effects (SAFTEE). Other than that detail, hematological (CBC), biochemical (fasting blood sugar, fasting lipids panel, thyroid function test, liver function test panel, renal function test panel), serology (HIV1/2, HBsAg, anti-HCV, VDRL), and urine routine and microscopy panel will be assessed for safety profile.Withdrawal effect will be measured using the Clinical Institute Withdrawal Assessment Scale - Benzodiazepines (CIWA-B) at 9 weeks 1 after discontinuation of test medicine. Clinical efficacy will be assessed by examining the improvement score at treatment endpoint in a multivariable linear regression analysis with group and baseline score as the independent variables. A completer analysis of clinical efficacy will also be performed, and a sensitivity analysis on patients who were at least 90% adherent during the course of the study. All other efficacy and safety outcomes will be assessed in completer analyses because imputation of missing data in these contexts would be scientifically meaningless. Alpha for statistical significance will be set at p<0.05. |