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CTRI Number  CTRI/2020/10/028656 [Registered on: 27/10/2020] Trial Registered Prospectively
Last Modified On: 23/11/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to evaluate Vitality Booster Capules for the management of stress and improvement of vitality 
Scientific Title of Study   Evaluation of efficacy and safety of Vitality Booster Capsules in the management of Stress and Improvement of Vitality in Adults: A prospective, randomised, double-blind, single center, placebo-controlled, interventional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AWPL-NGRA-SV  Other 
SBS/AWPL/NGRA/072010 Version 1.0 Date: 29th July 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Giriraja KV 
Designation  Consultant Physician 
Affiliation  Rajalakshmi Hospital 
Address  Department of General Medicine, Rajalakshmi Hospital, Lakshmipura Main Road, Vidyaranyapura Post, Bangalore

Bangalore
KARNATAKA
560097
India 
Phone  9738877298  
Fax    
Email  drgirirajkv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr C M Reddy 
Designation  Chief Scientific Offer 
Affiliation  Amitojas Wellness Private Limited 
Address  2nd Floor, JK Arcade Jayaberi Park, Kompally, Hyderabad

Hyderabad
TELANGANA
500014
India 
Phone  8885324455  
Fax    
Email  cso@amitojas.com  
 
Details of Contact Person
Public Query  
Name  Mr Kamal Kammili 
Designation  Director - Operations 
Affiliation  Sanjeevani Bio Services Private Limited 
Address  Raghavendra Colony, Kondapur, Hyderabad

Hyderabad
TELANGANA
500084
India 
Phone  04048593559  
Fax    
Email  kamal.kammili@sanjeevanibio.com  
 
Source of Monetary or Material Support  
Amitojas Wellness Private Limited 
Rajalakshmi Hospital 
 
Primary Sponsor  
Name  Amitojas Wellness Private Limited 
Address  2nd Floor, JK Arcade Jayaberi Park, Kompally, Hyderabad, Telangana – 500014, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Giriraja KV  Rajalakshmi Hospital  Department of General Medicine, Lakshmipura main road, Vidyaranyapura post, Bangalore
Bangalore
KARNATAKA 		 9738877298

drgirirajkv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajalakshmi Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F430||Acute stress reaction, (2) ICD-10 Condition: N528||Other male erectile dysfunction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo Capsules  The placebo capsules are similar to the Vitality Booster Capsules excpet they do not contain Active Ingredients. One capsule of study treatment is to be administered orally twice a day 
Intervention  Vitality Booster Capsules  Vitality Booster Capsules is a nutraceutical product, formulated as a capsule which has Ashwagandha Extract, Proprietary Terminalia Blend and Sarpagandha (2% Alpha Yohimbine). One capsule of study treatment is to be administered orally twice a day 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  1. Male subjects aged ≥ 18 years and ≤ 60 years.
2. Subjects who are experiencing mild to moderate stress; stress score ≥15 to ≤ 25 as per 21 item Depression, Anxiety, Stress Scale (DASS-21) at screening
3. Subjects with score 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit.
4. Subjects should be in an active stable sexual relationship for the entire duration of study
5. Subjects willing to provide informed written consent. 
 
ExclusionCriteria 
Details  1. Subjects with significant medical/surgical condition which requires long-term treatment.
2. Subjects with anatomical abnormalities of the penis.
3. Subjects who are currently being treated with other anti-stress and/or erectile dysfunction drugs.
4. Alcohol or substance abuse
5. Allergy or sensitivity to any of the ingredients in the study treatment
6. Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly.
7. Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study. 
 
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 
DASS-21 score documented in the CRF at baseline, day 15, and day 30 (values and change from baseline - within the group and between the groups comparisons)  baseline, day 15, and day 30  
 
Secondary Outcome  
Outcome  TimePoints 
International Index of Erectile Function (IIEF) domain scores documented in the CRF at baseline and day 30 (values and change from baseline - within the group and between the groups comparisons)  baseline and day 30 
36 item Short Form Survey (SF-36) domain scores documented in the CRF at baseline and day 30 (values and change from baseline - within the group and between the groups comparisons)  baseline and day 30 
Serum Cortisol levels documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)  baseline and day 30 
Serum Testosterone levels documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)  baseline and day 30 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   30/10/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Sexual health is a vital part of life required for good health and reproduction. Poor sexual health, either by psychological or pathological factors, can significantly affect the quality of life of adolescent and adult men. Sexual dysfunction (SD) is a condition of sexual behaviour and sexual sensation that emerges as an abnormality or absence of sexual psychology and physiological reaction. Clinical features of sexual dysfunction in men include erectile dysfunction (ED), premature ejaculation, failure of sexual intercourse and loss of libido/desire.The prevalence of premature ejaculation and erectile dysfunction were about 43.0% and 47.8% in India, respectively. Many factors can contribute to sexual dysfunction in men, including age, lower education, socioeconomic status, stress, perceived health, comorbidities and the medications used to treat them. Physical and psychological stress plays a crucial role in SD. In modern life, majority of the people are experiencing physical stress due to their targets, deadlines, long working hours, night duties, and travel responsibilities in various professions ranging from information technology to pharmaceutical promotion.
In stress induced low vitality, appropriate psychological evaluation is important in addition to appropriate medical treatment. The important treatment strategies such as distraction, physical activities, relaxation, socialising and healthy food, may be employed in order to get out of the stressful situation. Cognitive-behavioural approach and relaxation training plays a vital role in stress induced sexual dysfunction. Previous studies demonstrated that use of antipsychotics in patients with sexual dysfunction results in development of hyperprolactinemia. Dose reduction or use of prolactin-sparing drugs are recommended in those patients. Although, PDE5 inhibitors should be contraindicated in men who are on nitrates and alpha for postural hypotension may be a problem. Therefore, effective prevention and management of sexual dysfunction caused by various risk factors is important in clinical practice.Sexual dysfunction can be managed using herbal medicines/ nutraceuticals, due to their long history of utilization; moreover, natural products have gained increasing interest for maintaining good health worldwide. Therefore, the aim of the present is to assess the effect of nutraceutical products in stress induced low vitality in men.
 
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