Premature EjaculationNCT06571318
Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men
A study testing Destress and Perform Capsule-U001 and Destress and Perform Capsule-I001 in people with Premature Ejaculation and Stress, run by Herbolab India Pvt. Ltd..
Trial summary
The current study focuses on clinical validation of efficacy of nutraceutical product in management of male health. In healthy adult men with induced premature ejaculation, the introduction of these nutraceuticals has been associated with notable improvements in quality of life. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation, Stress
- What is being tested?
- Destress and Perform Capsule-U001 and Destress and Perform Capsule-I001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2024to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants aged 21-50 years both inclusive suffering from a. PE or b. ED
- Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26
- Participant having baseline IELT of less than 2 min
- Participants meeting with diagnostic criteria for PEP score greater than or equal to 11
- Participants who have scored 11 to 25 on the Erectile Function EF domain of the International Index of Erectile Function IIEF at screening visit a subset of 15 patients only that is 5 participants from each group
- Participants should be in an active stable sexual relationship only married participants for the entire duration of the study
- Participants willing to participate in clinical trials and who have read understood and signed the informed consent form.
Who cannot join
- Previous events or other severe conditions that may affect premature ejaculation/erectile dysfunction, including but not limited to spinal trauma or pelvic surgery
- Participants with genital anatomical deformities, including but not limited to penile deformities
- Participants for whom sexual activity is inadvisable because of their underlying disease status
- Female partners experiencing sexual dysfunction, such as painful intercourse, low libido, or other forms of sexual dysfunction, as well as pregnant individuals
- Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion. cardiovascular, b) cerebrovascular, c) dermatological, d) gastrointestinal, e) gynaecological, f) hematological, g) hepatic, h) malignancy, i) metabolic, j) musculoskeletal, k) neurological, l) psychiatric, m) thyroid n) psychological, o) renal, p) respiratory, q) venereal, r) any other major disorders
- Participants that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs;
Show all 13Show fewer
- Participants with history or presence of significant alcoholism or drug abuse within the past 1 year
- Participants with history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products more than 10 times per day
- Any concomitant treatment that is not permissible including but not limited to (nitrates, anti-androgens, chemotherapy agents, radiotherapy, etc).
- Recent participation in another clinical trial or receiving some other drug during the study besides that in the protocol
- Known hypersensitivity to any of the ingredients of investigational product
- 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, nutraceutical, or ayurvedic supplement for stress and/or PE management
- Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double Blind, Placebo-controlled, Parallel Arm Clinical Trial of De-Stress and Perform Capsule in the Management of Stress-induced Premature Ejaculation in Healthy Adult Men
The current study focuses on clinical validation of efficacy of nutraceutical product in management of male health. In healthy adult men with induced premature ejaculation, the introduction of these nutraceuticals has been associated with notable improvements in quality of life. These supplements help them for enhanced sexual satisfaction, increased control over ejaculation, and a reduction in performance anxiety. The psychological benefits are significant, as the improvement in sexual function can lead to higher self-confidence and a more positive outlook on life.
Read the detailed description
This will be a randomized, double-blind, placebo-controlled, parallel arm clinical trial of De-Stress and Perform Capsule in the management of stress-induced premature ejaculation in healthy adult men.
More than 60 participants will be randomized into three groups: Group A: De-Stress and Perform Capsule-U001 (20 participants), Group B: De-Stress and Perform Capsule-I001 (20 participants), Group C: Placebo Capsule-002 (20 participants) in a 1:1:1 ratio. The treatment duration will be 60 days. The efficacy of the investigational products will be compared between the groups.
Concomitant diseases/medication assessment will be performed at screening.
The efficacy of the intervention will be assessed by evaluating the following: changes in Perceived Stress Scale (PSS) score; changes in Premature Ejaculation Profile (PEP) score, including PEP control, PEP satisfaction, PEP distress, PEP relationship problems, and PEP Index Score; changes in sexual stamina using Intravaginal Ejaculatory Latency Time (IELT) score; changes in Libido System Score (LSS) score; changes in levels of serum testosterone, cortisol, and LDH; changes in weight and BMI; changes in COPE Questionnaire scores, including Positive Subscale and Denial Subscale; changes in % fat and % skeletal muscle using Bioelectrical Impedance Analysis (BIA); and changes in handgrip strength using a hand-held dynamometer, assessed at screening, day 30, and day 60.
Additionally, changes in blood flow will be assessed by penile Doppler in erectile dysfunction (ED) participants (a subset of 15 participants, i.e., 5 participants from each group). Changes in State-Trait Anxiety Inventory (STAI) score; changes in Profile of Mood States (POMS) questionnaire scores, including Total Mood Disturbance and Depression; changes in cardiorespiratory endurance (maximal oxygen uptake VO2 max) by steps test; and changes in Personal Assessment of Intimacy in Relationships (PAIR) scores (to be completed by partner) will also be evaluated at screening and day 60.
Treatment compliance and tolerability of investigational products will be assessed at day 30 and day 60. Safety of the investigational treatment in terms of adverse events (AEs) and serious adverse events (SAEs) will be assessed at baseline, day 30, and day 60. Assessments of changes in vital sign parameters will be done thought the visit. Assessments of changes in complete blood count, liver function test, and kidney function test will be done at screening and day 60.
- Conditions
- Premature Ejaculation, Stress
- Being tested
- Destress and Perform Capsule-U001, Destress and Perform Capsule-I001, Placebo capsules 002
- Keywords
- Premature Ejaculation, Stress
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Destress and Perform Capsule-U001Other
Two Capsules in sequence daily after meal for 60 days.
Destress and Perform Capsule-I001Other
Two Capsules in sequence daily after meal for 60 days.
Placebo capsules 002Other
Two Capsules in sequence daily after meal for 60 days
| Study group | Role | What they receive |
|---|---|---|
| Destress and Perform Capsule-U001 | Experimental | Not described Receives: Other: Destress and Perform Capsule-U001 |
| Destress and Perform Capsule-I001 | Experimental | Not described Receives: Other: Destress and Perform Capsule-I001 |
| Placebo capsules 002 | Other | Not described Receives: Other: Placebo capsules 002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
The PSS-10 is widely used for measuring psychological distress. It contains 10 questions on a five-point scale from 0 to 4. The higher the score, the greater the feeling of stress. PSS-10 Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Measured: Screening, day 30 and day 60
Premature ejaculation assessed using Premature Ejaculation Profile (PEP) Questionnaire
Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
Measured: Screening, day 30 and day 60
Sexual stamina assessed using intravaginal ejaculatory latency time (IELT)
Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred. Greater the time duration greater will be the sexual stamina
Measured: Screening, day 30 and day 60
libido system score (LSS)
The Stamina Libido System Score (Often Abbreviated as SLS Score) is a Metric used to assess various aspects of Sexual health, stamina, and libido. Scoring system aims to Total Score Interpretation 0-2: loss of libido; 3-4: low libido; 5-7: good libido, and 8-12: high libido.
Measured: Screening, day 30 and day 60
Changes in serum testosterone
The testosterone secretion will be evaluated by measuring serum testosterone levels
Measured: Screening, day 30 and day 60
Changes in Lactate dehydrogenase(LDH)
Blood level Lactate dehydrogenase was measured. (U/L)
Measured: Screening, day 30 and day 60
Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches' x Height in inches)) x 703
Measured: Screening, day 30 and day 60
COPE Questionnaire
Problem-Focused Coping: A high score indicates coping strategies that are aimed at changing the stressful situation. High scores are indicative of psychological strength, grit, a practical approach to problem solving and is predictive of positive outcomes.
Emotion-Focused Coping: A high score indicates coping strategies that are aiming to regulate emotions associated with the stressful situation. High or low scores are not uniformly associated with psychological health or ill health, but can be used to inform a wider formulation of the respondent's coping styles.
Avoidant Coping: A high score indicates physical or cognitive efforts to disengage from the stressor. Low scores are typically indicative of adaptive coping.
Measured: Screening, day 30 and day 60
Assessment of Maximum oxygen consumption
Maximum oxygen consumption (VO2 max) should be calculated by the following equation:
VO2 max (mL/kg/min) = 111.33 - (0.42 × heart rate (bpm))
Measured: Screening, day 30 and day 60
Assessment of % fat using bioelectrical impedance analysis (BIA)
It is calculated in terms of percentage
Measured: Screening, day 30 and day 60
Assessment of % skeletal muscle using bioelectrical impedance analysis (BIA)
It is calculated in terms of percentage.
Measured: Screening, day 30 and day 60
Handgrip strength
To measure hand grip strength through Hydraulic Hand held Dynamo-meter. It will be measured in Kilogram force.
Measured: Screening, day 30 and day 60
STAI (State-Trait Anxiety Inventory)
STAI: State-Trait-Anxiety-Inventory-Score This test consists of 20 items and assesses the current state of anxiety in relation to the current situation in which the patient is to the current situation in which the patient finds herself (State Anxiety) and the general anxiety state existing state of anxiety, which represents a part of her personality (Trait Anxiety).
The sum score has a range from 20-80. Its interpretation with respective score are discussed below:
mild anxiety (20 to 39); moderate anxiety (40 to 59); intense anxiety (60 to 80).
Measured: Screening and day 60
Profile of Mood State (POMS) questionnaire
The Profile of Mood States (POMS) is a widely used instrument that measures mood using a 40 item questionnaire with each item rated using a response scale of five categories ranging from "not at all" to "Extremely". Higher score indicates worse mood. Total POMS score categories and stress inference:0-40 = A little; 81-120= Quite a lot; 41-80= Moderately; 121-160= Extremely.
Measured: Screening and day 60
Intimacy problems
Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory.
Measured: Screening and day 60
Assessment of blood flow
Assessment of blood flow using penile Doppler-
- Peak systolic velocity of the CA (cavernosal artery) - Indicator of arterial influx: Normal: >35 cm/sec, Gray zone: 25-35 cm/sec Abnormal.
- End diastolic velocity of the CA - Normal: 5 cm/sec, Diastolic flow reversal: reliable indicator of intact veno-occlusive mechanism.
- Deep dorsal vein - Normal: 20 cm/sec, Moderate increase: 10-20 cm/sec, Marked increase: >20 cm/sec
- Arterial compliance of the CA - 60%-75% increase in diameter Ø Evident pulsation
- Resistive index of the CA - Normal: >0.9, Venous leak: <0.75
Measured: Screening and day 60
Secondary outcomes (9)
Safety of participant Assessed using adverse events
It is measure in terms of No. of events
Measured: Screening, baseline, day 30, day 60
Safety of participant Assessed using treatment compliance and tolerability of investigational product
It is measure in terms of percentage
Measured: Screening, baseline, day 30, day 60
Systolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Measured: Screening, baseline, day 30, day 60
Diastolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Measured: Screening, baseline, day 30, day 60
Pulse rate difference from reference measurement (beats per minute)
Assessed against standard clinical grade instrument: Finger-based pulse oximeter (beats per minute)
Measured: Screening, baseline, day 30, day 60
Complete blood count
White blood cell and platelet count [Thousand per microliter (Thousand/uL)] Red blood cell count [Millions per microliter (million/uL)]
Measured: Screening and day 60
Serum Glutamic Pyruvic Transaminase (SGPT)
Blood level of SGPT was measured. (U/L)
Measured: Screening and day 60
Serum glutamic-oxaloacetic transaminase (SGOT)
Blood level of SGOT was measured. (U/L)
Measured: Screening and day 60
Creatinine difference from reference measurement (mg/dl)
Blood levels of Creatinine was measured. (mg/dl)
Measured: Screening and day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start5 Sep 2024 (estimated)
- Primary completion20 Nov 2024 (estimated)
- Study completion28 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double blind, Parallel Group, Placebo Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herbolab India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Ramshyam Agarwal, MBBS, DNB, Principal investigator, Lokmanya Medical Research Centre and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571318
- Sponsor's protocol ID
- MHC/CT/24-25/018
- Other IDs
- CTRI/2024/07/071256
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled, Parallel Arm Clinical Trial of De-Stress and Perform Capsule in the Management of Stress-induced Premature Ejaculation in Healthy Adult Men
- ClinicalTrials.gov ID
- NCT06571318
- Acronym / sponsor ID
- MHC/CT/24-25/018
- Conditions
- Premature Ejaculation, Stress
- Keywords
- Premature Ejaculation, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Herbolab India Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2024 (estimated)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study focuses on clinical validation of efficacy of nutraceutical product in management of male health. In healthy adult men with induced premature ejaculation, the introduction of these nutraceuticals has been associated with notable improvements in quality of life. These supplements help them for enhanced sexual satisfaction, increased control over ejaculation, and a reduction in performance anxiety. The psychological benefits are significant, as the improvement in sexual function can lead to higher self-confidence and a more positive outlook on life.
Detailed description
This will be a randomized, double-blind, placebo-controlled, parallel arm clinical trial of De-Stress and Perform Capsule in the management of stress-induced premature ejaculation in healthy adult men.
More than 60 participants will be randomized into three groups: Group A: De-Stress and Perform Capsule-U001 (20 participants), Group B: De-Stress and Perform Capsule-I001 (20 participants), Group C: Placebo Capsule-002 (20 participants) in a 1:1:1 ratio. The treatment duration will be 60 days. The efficacy of the investigational products will be compared between the groups.
Concomitant diseases/medication assessment will be performed at screening.
The efficacy of the intervention will be assessed by evaluating the following: changes in Perceived Stress Scale (PSS) score; changes in Premature Ejaculation Profile (PEP) score, including PEP control, PEP satisfaction, PEP distress, PEP relationship problems, and PEP Index Score; changes in sexual stamina using Intravaginal Ejaculatory Latency Time (IELT) score; changes in Libido System Score (LSS) score; changes in levels of serum testosterone, cortisol, and LDH; changes in weight and BMI; changes in COPE Questionnaire scores, including Positive Subscale and Denial Subscale; changes in % fat and % skeletal muscle using Bioelectrical Impedance Analysis (BIA); and changes in handgrip strength using a hand-held dynamometer, assessed at screening, day 30, and day 60.
Additionally, changes in blood flow will be assessed by penile Doppler in erectile dysfunction (ED) participants (a subset of 15 participants, i.e., 5 participants from each group). Changes in State-Trait Anxiety Inventory (STAI) score; changes in Profile of Mood States (POMS) questionnaire scores, including Total Mood Disturbance and Depression; changes in cardiorespiratory endurance (maximal oxygen uptake VO2 max) by steps test; and changes in Personal Assessment of Intimacy in Relationships (PAIR) scores (to be completed by partner) will also be evaluated at screening and day 60.
Treatment compliance and tolerability of investigational products will be assessed at day 30 and day 60. Safety of the investigational treatment in terms of adverse events (AEs) and serious adverse events (SAEs) will be assessed at baseline, day 30, and day 60. Assessments of changes in vital sign parameters will be done thought the visit. Assessments of changes in complete blood count, liver function test, and kidney function test will be done at screening and day 60.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, Double blind, Parallel Group, Placebo Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Destress and Perform Capsule-U001 | Experimental | Other: Destress and Perform Capsule-U001 |
| Destress and Perform Capsule-I001 | Experimental | Other: Destress and Perform Capsule-I001 |
| Placebo capsules 002 | Other | Other: Placebo capsules 002 |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male participants aged 21-50 years both inclusive suffering from a. PE or b. ED
- Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26
- Participant having baseline IELT of less than 2 min
- Participants meeting with diagnostic criteria for PEP score greater than or equal to 11
- Participants who have scored 11 to 25 on the Erectile Function EF domain of the International Index of Erectile Function IIEF at screening visit a subset of 15 patients only that is 5 participants from each group
Key exclusion criteria (13 listed)
- Previous events or other severe conditions that may affect premature ejaculation/erectile dysfunction, including but not limited to spinal trauma or pelvic surgery
- Participants with genital anatomical deformities, including but not limited to penile deformities
- Participants for whom sexual activity is inadvisable because of their underlying disease status
- Female partners experiencing sexual dysfunction, such as painful intercourse, low libido, or other forms of sexual dysfunction, as well as pregnant individuals
- Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion. cardiovascular, b) cerebrovascular, c) dermatological, d) gastrointestinal, e) gynaecological, f) hematological, g) hepatic, h) malignancy, i) metabolic, j) musculoskeletal, k) neurological, l) psychiatric, m) thyroid n) psychological, o) renal, p) respiratory, q) venereal, r) any other major disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Destress and Perform Capsule-U001Two Capsules in sequence daily after meal for 60 days. | Other | Destress and Perform Capsule-U001 |
| Destress and Perform Capsule-I001Two Capsules in sequence daily after meal for 60 days. | Other | Destress and Perform Capsule-I001 |
| Placebo capsules 002Two Capsules in sequence daily after meal for 60 days | Other | Placebo capsules 002 |
Primary outcome
Perceived Stress Scale
Time frame: Screening, day 30 and day 60
The PSS-10 is widely used for measuring psychological distress. It contains 10 questions on a five-point scale from 0 to 4. The higher the score, the greater the feeling of stress. PSS-10 Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Premature ejaculation assessed using Premature Ejaculation Profile (PEP) Questionnaire
Time frame: Screening, day 30 and day 60
Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
Sexual stamina assessed using intravaginal ejaculatory latency time (IELT)
Time frame: Screening, day 30 and day 60
Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred. Greater the time duration greater will be the sexual stamina
libido system score (LSS)
Time frame: Screening, day 30 and day 60
The Stamina Libido System Score (Often Abbreviated as SLS Score) is a Metric used to assess various aspects of Sexual health, stamina, and libido. Scoring system aims to Total Score Interpretation 0-2: loss of libido; 3-4: low libido; 5-7: good libido, and 8-12: high libido.
Changes in serum testosterone
Time frame: Screening, day 30 and day 60
The testosterone secretion will be evaluated by measuring serum testosterone levels
Changes in Lactate dehydrogenase(LDH)
Time frame: Screening, day 30 and day 60
Blood level Lactate dehydrogenase was measured. (U/L)
Body Mass Index (BMI)
Time frame: Screening, day 30 and day 60
Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches' x Height in inches)) x 703
COPE Questionnaire
Time frame: Screening, day 30 and day 60
Problem-Focused Coping: A high score indicates coping strategies that are aimed at changing the stressful situation. High scores are indicative of psychological strength, grit, a practical approach to problem solving and is predictive of positive outcomes. Emotion-Focused Coping: A high score indicates coping strategies that are aiming to regulate emotions associated with the stressful situation. High or low scores are not uniformly associated with psychological health or ill health, but can be used to inform a wider formulation of the respondent's coping styles. Avoidant Coping: A high score indicates physical or cognitive efforts to disengage from the stressor. Low scores are typically indicative of adaptive coping.
Assessment of Maximum oxygen consumption
Time frame: Screening, day 30 and day 60
Maximum oxygen consumption (VO2 max) should be calculated by the following equation: VO2 max (mL/kg/min) = 111.33 - (0.42 × heart rate (bpm))
Assessment of % fat using bioelectrical impedance analysis (BIA)
Time frame: Screening, day 30 and day 60
It is calculated in terms of percentage
Assessment of % skeletal muscle using bioelectrical impedance analysis (BIA)
Time frame: Screening, day 30 and day 60
It is calculated in terms of percentage.
Handgrip strength
Time frame: Screening, day 30 and day 60
To measure hand grip strength through Hydraulic Hand held Dynamo-meter. It will be measured in Kilogram force.
STAI (State-Trait Anxiety Inventory)
Time frame: Screening and day 60
STAI: State-Trait-Anxiety-Inventory-Score This test consists of 20 items and assesses the current state of anxiety in relation to the current situation in which the patient is to the current situation in which the patient finds herself (State Anxiety) and the general anxiety state existing state of anxiety, which represents a part of her personality (Trait Anxiety). The sum score has a range from 20-80. Its interpretation with respective score are discussed below: mild anxiety (20 to 39); moderate anxiety (40 to 59); intense anxiety (60 to 80).
Profile of Mood State (POMS) questionnaire
Time frame: Screening and day 60
The Profile of Mood States (POMS) is a widely used instrument that measures mood using a 40 item questionnaire with each item rated using a response scale of five categories ranging from "not at all" to "Extremely". Higher score indicates worse mood. Total POMS score categories and stress inference:0-40 = A little; 81-120= Quite a lot; 41-80= Moderately; 121-160= Extremely.
Intimacy problems
Time frame: Screening and day 60
Intimacy problems are assessed using the Personal Assessment of Intimacy in Relationships (PAIR) Inventory.
Assessment of blood flow
Time frame: Screening and day 60
Assessment of blood flow using penile Doppler- 1. Peak systolic velocity of the CA (cavernosal artery) - Indicator of arterial influx: Normal: >35 cm/sec, Gray zone: 25-35 cm/sec Abnormal. 2. End diastolic velocity of the CA - Normal: 5 cm/sec, Diastolic flow reversal: reliable indicator of intact veno-occlusive mechanism. 3. Deep dorsal vein - Normal: 20 cm/sec, Moderate increase: 10-20 cm/sec, Marked increase: >20 cm/sec 4. Arterial compliance of the CA - 60%-75% increase in diameter Ø Evident pulsation 5. Resistive index of the CA - Normal: >0.9, Venous leak: <0.75
9 secondary outcomes
Safety of participant Assessed using adverse events
Time frame: Screening, baseline, day 30, day 60
Safety of participant Assessed using treatment compliance and tolerability of investigational product
Time frame: Screening, baseline, day 30, day 60
Systolic blood pressure difference from reference measurement (mmHg)
Time frame: Screening, baseline, day 30, day 60
Diastolic blood pressure difference from reference measurement (mmHg)
Time frame: Screening, baseline, day 30, day 60
Pulse rate difference from reference measurement (beats per minute)
Time frame: Screening, baseline, day 30, day 60
Complete blood count
Time frame: Screening and day 60
Serum Glutamic Pyruvic Transaminase (SGPT)
Time frame: Screening and day 60
Serum glutamic-oxaloacetic transaminase (SGOT)
Time frame: Screening and day 60
Creatinine difference from reference measurement (mg/dl)
Time frame: Screening and day 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Ramshyam Agarwal, MBBS, DNB principal investigator
Lokmanya Medical Research Centre and Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Destress and Perform Capsule-U001 and Destress and Perform Capsule-I001 in people with Premature Ejaculation and Stress, run by Herbolab India Pvt. Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Kriti Soni, PhD (+91 9871018383, kriti.soni@rpsg.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: Screening, day 30 and day 60). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.