| CTRI Number |
CTRI/2019/05/019431 [Registered on: 30/05/2019] Trial Registered Prospectively |
| Last Modified On: |
27/09/2019 |
| 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 study to evaluate the efficacy and safety of Investigational Product SLEPOVIN in patients with Insomnia |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled Interventional Clinical Study to evaluate the efficacy and safety of Investigational Product SLEPOVIN in patients with Insomnia |
| Trial Acronym |
Insomnia |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| BIAG-CSP-025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JayKumar Gunjkar |
| Designation |
Consultant |
| Affiliation |
Lifepoint Multispecialty Hospital |
| Address |
Lifepoint Multispecialty Hospital
145/1 Mumbai Bypass Rd, Near Hotel Sayaji, Wakad, Pimpri-Chinchwad, Maharashtra
Mumbai
MAHARASHTRA
411023
India |
| Phone |
9767092120 |
| Fax |
|
| Email |
gunjkar.jaykumar118@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalini Dayanada |
| Designation |
General Manager |
| Affiliation |
Bio Agile Therapeutics Pvt. Ltd. |
| Address |
Bio Agile Therapeutics Pvt. Ltd.
#2/5, Dahlia Building, 3rd Floor,
80 Feet Road, RMV 2nd Stage,
Bangalore , INDIA
Bangalore
KARNATAKA
560094
India |
| Phone |
08043754520 |
| Fax |
|
| Email |
pm@bioagiletherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya C |
| Designation |
Director |
| Affiliation |
Bio Agile Therapeutics Pvt. Ltd. |
| Address |
Bio Agile Therapeutics Pvt. Ltd.
#2/5, Dahlia Building, 3rd Floor,
80 Feet Road, RMV 2nd Stage,
Bangalore , INDIA
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
|
Source of Monetary or Material Support
|
| Big Brother Nutra Care
Unit No. 1119, 11th Floor,
Andheri (East) Mumbai-400069 |
|
|
Primary Sponsor
|
| Name |
BigBrother Nutra Care Pvt Ltd |
| Address |
N. S. Phadke Marg Andheri (East) Mumbai-400069 (India) |
| 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 |
| JayKumar Gunjkar |
Lifepoint Multispecialty Hospital |
145/1 Mumbai Bypass Rd, Near Hotel Sayaji, Wakad, Pimpri-Chinchwad, Maharashtra 411023
Pune
MAHARASHTRA |
9767092120
gunjkar.jaykumar118@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lifepoint Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
500mg capsule to be taken orally once daily for 30 days |
| Intervention |
SLEPOVIN |
500mg capsule to be taken orally, once daily for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects aged above 18 years old (inclusive)
2. Subject is in good physical status and mental health
3. Male or female subjects aged above 18 years old (inclusive)
4.Subject is in good physical status and mental health
5. Sleep onset insomnia (difficulty taking sleep at the beginning of the night)
6. Sleep maintenance insomnia (difficulty in maintaining the sleep)
7. Nocturnal awakenings, difficulty in retuning to sleep after awakening in the middle of the night or wakening early in the morning
8. Insomnia severity index > 7
9. Subject is willing to limit alcohol, caffeine, and nicotine consumption while in the study
10. Habitual bedtime between 8.30 pm and midnight
11. Able and willing to follow all study related instructions and to complete all required visits
12. Subjects willing to give inform consent for participation
|
|
| ExclusionCriteria |
| Details |
1. Subjects with clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological or neurological illness (es)
2. History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication
3. Subjects who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnea
4. Subjects with substance dependence/ abuse in the past one year or with alcohol abuse are ineligible
5. Subjects taking certain prohibited medications
6. Females who are pregnant, lactating or likely to become pregnant during the study
7. Subjects using tobacco products or caffeinated beverages during night awakenings.
8. Clinical history of allergy/ hypersensitivity to one or more products of herbal origin. Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 3 month
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Mean change in Subjective Sleep Onset Latency (sSOL) (Time frame: Beginning of placebo-controlled treatment 1 month of placebo-controlled treatment.
• Mean change in Subjective Sleep Efficiency (sSE)
• Mean change in sSOL, sWASO, and Subjective Total Sleep Time (sTST)
|
Day 0 Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Change in Insomnia Severity Index from baseline to end of visit
• Changes in Epworth Sleepiness Scale from baseline to end of visit
• Monitor any adverse event on (Day 15±1) and Day30±2 |
Day 0 Day 30 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2019 |
| Date of Study Completion (India) |
21/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Sleep disorders are a common ailment in current
society, one that has significant implications for public health1. Insomnia,
the most common of those sleep disorders, is defined by the Diagnostic and
Statistical Manual of Mental Disorders, Fourth Edition as difficulty
initiating sleep, difficulty maintaining sleep, or difficulty obtaining
restorative sleep with associated daytime dysfunction or distress due to that
lack of sleep2. It is associated with significant health problems
including reduced quality of life, work productivity, and mental health.
Insomnia has a high prevalence in society; and although numbers vary,
approximately two thirds of adults will have one or more episodes of insomnia
each year, and approximately 15% of adults per year will have a serious chronic
episode3. Insomnia is the most common sleep disorder affecting
millions of people as either a primary or comorbid condition4.
Insomnia has been considered as both a symptom and a disorder, and this
distinction may affect its conceptualization from both research and clinical perspectives.The
current therapeutic options in Insomnia patients include pharmacological,
psychological, and complementary approaches. Pharmacologic medications include
benzodiazepine hypnotics, non-benzodiazepine, and melatonin receptor agonists. Due to associated adverse events with
pharmacologic treatments, insomnia patients are switching to alternative
therapy such as herbal medications, alternative therapy encompasses a variety
of disciplines that include everything from diet and exercise to mental conditioning
and lifestyle changes such as acupuncture, guided imagery, yoga, hypnosis, biofeedback, aromatherapy, relaxation, herbal
remedies, massage, and many others.
|