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CTRI Number  CTRI/2022/05/042818 [Registered on: 25/05/2022] Trial Registered Prospectively
Last Modified On: 28/08/2023
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 comparative study on human healthy volunteers with Sleep problems 
Scientific Title of Study   A Prospective, Randomized, Double-Blind, Parallel, Placebo- Controlled Study to Evaluate the Efficacy of Valerian on Sleep in Subjects with Sleep Complaints. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harshith C S 
Designation  Principal Investigator 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of General Medicine, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri,

Bangalore
KARNATAKA
560060
India 
Phone  9482164779  
Fax    
Email  harsh0594@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jestin V Thomas  
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd 
Address  Department of Clinical Research, #9, 1st floor, Mythri Legacy, Chelekere main road, Kalyan Nagar

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jestin V Thomas  
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd 
Address  Department of Clinical Research, #9, 1st floor, Mythri Legacy, Chelekere main road, Kalyan Nagar

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Source of Monetary or Material Support  
OmniActive Health Technologies T8A, Wing A, Phoenix House, 462, Senapati Bapat Marg, Lower Parel, Mumbai 400013  
 
Primary Sponsor  
Name  OmniActive Health Technologies 
Address  T8A, Wing A, Phoenix House, 462, Senapati Bapat Marg, Lower Parel, Mumbai 400013 
Type of Sponsor  Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] 
 
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 Harshith C S   BGS Global Institute of Medical Sciences   Department of General Medicine, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri,
Bangalore
KARNATAKA 		 9482164779

harsh0594@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  with sleep disturbances 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo, 200 mg  Micro crystalline cellulose, 200 mg every night for 56 days 
Intervention  Valerian, 200 mg capsule  Valerian, 200 mg capsule, every night for 56 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.BMI of 18.5 kg/m2 to 29.9 kg/m2 (both limits inclusive)
2.Pittsburgh sleep quality index (PSQI) score of 5 and above
3.Insomnia Severity Index (ISI) score of 14 and below
4.Beck Anxiety Inventory (BAI) score of 15 and below
5.Subjects who agree to maintain their usual level of activity throughout the trial period and willing to refrain from vigorous physical activity within 2 hours of bedtime.
6.Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period.
7.Subjects willing to consume the study product 30 minutes before bed throughout the study period.
8.Subjects willing to refrain from taking any medications or preparations to improve sleep (herbal, dietary supplements, homeopathic preparations, etc.) during the study
9.Subjects willing to consume no more than 4 servings of caffeine substances per day and no caffeine within 6 hours of bedtime.
10.Subjects who agree to stay weight stable during the study period.
11.Female subjects of child bearing potential practicing an acceptable method of birth control such as Intrauterine Device in place for at least 3 months prior to the start of the study and remaining in place during the study period, contraceptive transdermal, injection or implants, non-hormonal or hormonal, abstinence: Subjects who shall be practicing abstinence shall agree to have a documented second acceptable method of birth control should the subject become sexually active during the course of her study participation for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment.
OR
Postmenopausal for at least 1 year.
OR
Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/hysterectomy has been performed on the subject).
12.Subjects willing to provide written consent.
13.Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
 
 
ExclusionCriteria 
Details  1.Having hypersensitivity or history of allergy to the study product.
2.Subjects with a malignant disease or any concomitant end- state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection
3.Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator.
4.Subjects with a psychiatric diagnosis other than anxiety or depression.
5.Subjects with uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg) at screening.
6.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications.
7.Subject has a history of unconventional sleep patterns (e.g., night shift), chronic insomnia (defined as insomnia at least 3 days/week over the past month), a diagnosed sleep disorder (e.g., OSA), or a chronic medical condition that may impact energy/fatigue levels, in the judgment of the investigator
8.Subjects with a history of drug and /or alcohol abuse at the time of enrolment
9.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
10.Subjects with positive Urine Pregnancy Test at Screening/Randomization Visit.
11.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
12.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Sleep Quality Index and Sleep Latency compared to Placebo  Day 0, Day 3, Day 14, Day 28, Day 56 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Actigraphy based assessment parameters  Day 0, Day 3, Day 14, Day 28, Day 56 
Change in Polysomnography based assessment parameters  Day 0, Day 56 
Change in Questionnaire based assessments  Day 0, Day 3, Day 14, Day 28, Day 56 
Change in Epworth Sleepiness Scale  Day 0, Day 3, Day 14, Day 28, Day 56 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/05/2022 
Date of Study Completion (India) 14/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   "NILL" 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a randomized, double-blind, parallel, placebo-controlled, clinical interventional study. Adult healthy males and/or females with sleep complaints, aged between 18 and 50 years and meeting all inclusion and no exclusion criteria will be enrolled in the study after signing a written informed consent. Clinical assessments will include questionnaire based assessments, wrist actigraphy ,polysomnography and Epworth Sleepiness Scale .There will be 3 follow-up visits at Day 3, Day 14 and Day 28  followed by End of study visit on Day 56. Safety assessments will include monitoring of Adverse Events (AEs), physical examination, vital signs measurement, Urine Pregnancy Tests (for females of childbearing potential), Hematology and clinical chemistry tests.

  
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