| CTRI Number |
CTRI/2020/05/025286 [Registered on: 21/05/2020] Trial Registered Prospectively |
| Last Modified On: |
02/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
This is a mono-center study wherein the efficacy and safety of formulation for vitality, vigour, sexual well-being will be studied in adult male patients. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo controlled clinical study to evaluate the efficacy and safety of the formulation for vitality, vigour, sexual well-being and improvement in quality of life in ageing males. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CPL/84/AK2C_EDYS/I/OCT/19,V2.0,16-FEB-2021 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Vikneswaran G |
| Designation |
Clinical Research Consultant |
| Affiliation |
Narayana Health |
| Address |
Room No. 258/A, Bommasandra Industrial Area, Anekal Taluk, Hosur Road, Bommasandra. Bangalore.
Bangalore
KARNATAKA
560099
India |
| Phone |
09787649182 |
| Fax |
|
| Email |
vikneswaran.g.dr@narayanahealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpesh Shah |
| Designation |
Senior Vice President |
| Affiliation |
ClinWorld Private Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka.
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
kalpesh@clinworld.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpesh Shah |
| Designation |
Senior Vice President |
| Affiliation |
ClinWorld Private Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka.
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
kalpesh@clinworld.org |
|
|
Source of Monetary or Material Support
|
| Sami Labs Limited
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka. 560058. |
|
|
Primary Sponsor
|
| Name |
Sami Labs Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka. 560058. |
| Type of Sponsor |
Other [Manufactures & markets phutonutrients, standardized herbal extracts and nutritional supplements.] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vikneswaran G |
Narayana Health |
258/A, Bommasandra Industrial Area, Anekal Taluk, Hosur Road, Bommasandra, Bangalore. 560099.
Bangalore
KARNATAKA |
09787649182
vikneswaran.g.dr@narayanahealth.org |
| Dr S V Krishna Reddy |
Vijaya Super Speciality Hospital |
Urology Centre,Raghava Cine Complex Road, Pogathota, SPSR-Nellore, Andhra Pradesh. 524001.
Nellore
ANDHRA PRADESH |
09849048222
svkkrishnareddy.vijaya@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Narayana Health Medical Ethics Committee |
Approved |
| Vijaya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F529||Unspecified sexual dysfunction notdue to a substance or known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo (Microcrystalline cellulose) |
Two tablets of 620 mg each a day before dinner for 60 days. |
| Intervention |
XXtra strong |
Two tablets of 620mg each a day before dinner for 60 days. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1 Married male subjects of age ranging from 35-60 years with both years inclusive (minimum age being 35 years and maximum age being 60 years).
2 Complaints with symptoms of fatigue and diminished vitality with AMS questionnaire score ≥27 and ≤ 42.
3 Self-reported Mild to moderate Erectile problems with IIEF-5 score ≥12 and ≤ 21 with difficulty in maintaining erection or premature ejaculation.
4 The subjects must be in a marital relationship (Married), having stable monogamous sexual relationship with a female for a minimum of last 06 months and continue throughout till the end of the study.
5 Physically active and Planning to have regular sexual activity.
6 Commitment to comply with study protocol requirements.
7 Willing to sign informed consent. |
|
| ExclusionCriteria |
| Details |
1 History of smoking, alcohol intake and narcotic/drug abuse within 3 months before Screening.
2 Subjects who want to lose weight or looking for weight loss program or significant lifestyle related modifications during the study.
3 History of surgical interventions or subjects with major psychiatric and neurological disorders such as Schizophrenia,Mental disorders, Alzheimer’s, Parkinsonism and Epilepsy, Multiple sclerosis etc.), major trauma or infections that are associated with the development of symptoms of ED and considered a potential cause of ED, severe systemic disorders including blood diseases and leukemias.
4 Having genital abnormalities or anatomical deformity of the penis including severe penile fibrosis or Peyronies disease or phimosis or any other condition which prevents normal sexual intercourse.
5 With blood pressure more than or equal to 140/85 mmHg and those who were on a “chronic use†for a minimum of 12 months or more of the following class of drugs viz Diuretics, Beta blockers and Calcium channel blockers.Subjects with blood pressure less than 140/85 and on monotherapy or low dose combination therapy without change in the dose from past 06 months need not be excluded.
6 Subjects with HbA1c ≥ 6.5.
7 Subjects with history of clinically significant thyroid disorder (hypo or hyper), gastrointestinal, cardiovascular, haematological, hepatic (SGOT or SGPT levels > 2 times Upper Limit of Normal),renal (serum creatinine ≥ 1.3 mg/dl),dialysis,respiratory or genitourinary abnormalities or diseases.
8 BMI > 30 Kg/m2.
9 Subjects detected with HIV and suffering from AIDS or on antiviral or anti-retroviral therapy.
10 Subjects with any clinically significant laboratory or ECG findings during screening.
11 Those subjects with Premature Ejaculation and organic impotence and clinically defined prostatitis and who have undergone pelvic surgery.
12 Subjects who are taking medications for erectile dysfunction, Phosphodiesterase Type-5 Inhibitors including sildenafil, tadalafil, vardenafil, avanafil must stop using these medications for at least 04 weeks before baseline visit.
13 Subjects those are not willing to stop taking the vitamins and supplements including herbal during the course of the study.
14 Subject who are allergic to herbal supplements and medications.
15 Subjects continuing tricyclic antidepressant and atypical antipsychotic drugs for the last 03 months.
16 Subject having participated in any clinical trial within last 03 months or any trial for testosterone boosting or ED,vigour,vitality, male sexual health and performance trials.
17 Subjects not ready to provide the identification proof i.e. Age and Gender,not ready to sign the consent and unable to comply with the protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Improvement in psychological, somatic and sexual improvement through change in Aging Male’s Symptom Scale.
2 Improvement in erectile function in comparison to placebo through Improvement in IIEF-5 questionnaire score. |
1 Aging Male’s Symptom Scale(Screening,Day30 and Day60).
2 IIEF-5 questionnaire (Screening,Day30 and Day60). |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1 Change in total and free blood Testosterone level in comparison with placebo.
2 Change in Salivary Cortisol level in comparison with placebo.
3 Improvement in Health-Related Quality of Life through SF-36 Version 1 RAND Corporation questionnaire and AMS score
4 Safety will be assessed through occurrence of AE during the study duration, change in vital signs from screening to final visit.
5 Overall wellbeing through other parameters in comparison to placebo.
6 Hs-CRP test. |
1 Blood total and free Testosterone level(Baseline,Day30 and Day60).
2 Salivary Cortisol level (Baseline and Day60).
3 SF-36 and AMS score (Screening,Day30 and Day60)
4 AE and change in vital signs (Day30,Day60 and Day75(telephonic follow-up))
5 Overall wellbeing through other parameters in comparison to placebo(Day30,Day60 and Day75(telephonic follow-up).
6 Hs-CRP test (Day0 and Day60). |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/05/2020 |
| 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
|
Not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This proposed study is a randomized, double-blind, placebo-controlled trial, investigating the efficacy and safety of formulation (620 mg) for improvement in the symptoms associated with ageing like diminished vitality , vigour, erectile function and performance in comparison with placebo (620 mg) in men aged between 35-60 years. The improvement in symptoms will be analysed by the AMS scale; IIEF-5 score and associated serum bio-markers (testosterone & cortisol). All the parameters will be assessed before and after treatment based on the specially prepared proforma. Appropriate test will be applied to the data outcome and discussion and conclusion will be made accordingly. |