| CTRI Number |
CTRI/2022/11/047323 [Registered on: 15/11/2022] Trial Registered Prospectively |
| Last Modified On: |
12/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effects of Sleep/ Well’ capsules in patients having difficulty in sleeping |
|
Scientific Title of Study
|
A study to evaluate the effects of ‘Sleep/ Well’ capsules on Asian women subjects between the age of 25-40 years facing problems while initiating or maintaining sleep. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Astrid Velho |
| Designation |
Principal Investigator |
| Affiliation |
Spectrum Health Care |
| Address |
Spectrum Health Care 81_84 Lady Ratan Tata Medical &Research Centre
Maharshi Karve Road Cooperage Mumbai
Mumbai
MAHARASHTRA
400021
India
Mumbai
MAHARASHTRA
400021
India |
| Phone |
912268428800 |
| Fax |
|
| Email |
avelho@spectrumhealthcare.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Viral Shah |
| Designation |
Medical Director |
| Affiliation |
Spectrum Clinical Research Pvt Ltd |
| Address |
Spectrum Clinical Research Pvt Ltd
401 Kshamalaya Building
37_New Marine Lines
Mumbai MAHARASHTRA
400 020
India
Mumbai
MAHARASHTRA
400020
India |
| Phone |
912240645100 |
| Fax |
912266155567 |
| Email |
vshah@spectrumcr.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Viral Shah |
| Designation |
Medical Director |
| Affiliation |
Spectrum Clinical Research Pvt Ltd |
| Address |
Spectrum Clinical Research Pvt Ltd
401 Kshamalaya Building
37_New Marine Lines
Mumbai MAHARASHTRA
400 020
India
Mumbai
MAHARASHTRA
400020
India |
| Phone |
912240645100 |
| Fax |
912266155567 |
| Email |
vshah@spectrumcr.com |
|
|
Source of Monetary or Material Support
|
| MOOM HEALTH PTE LTD
1003, Bukit Merah Central
04-16, Singapore 159836 |
|
|
Primary Sponsor
|
| Name |
MOOM HEALTH PTE LTD |
| Address |
1003, Bukit Merah Central
04-16, Singapore 159836 |
| Type of Sponsor |
Other [supplements manufacturer] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spectrum Clinical Research Pvt Ltd |
New Marine Lines
Mumbai - 400 020,India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Astrid Velho |
Spectrum Health Care |
81 to 84 LadyRatan TataMedical &ResearchCentreMaharshi KarveRoadCooperageMumbai 400021
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
022-68428800
avelho@spectrumhealthcare.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Inter System Biomedica EthicsCommittee (ISBEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F510||Insomnia not due to a substance orknown physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Sleep well capsules |
Sleep/ Well is a herbal formula that consist of the following crude herbs: Valeriana Wallichi, Passiflora Incarnata, Ziziphus spinose, Melatonin, Glutamine. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Female participants with Age between 25-40 years.
2. Females facing problems while initiating or maintaining sleep.
3. Willing to participate in the study after informed consent.
4. Pittsburgh Sleep Quality Instrument score higher than 5 |
|
| ExclusionCriteria |
| Details |
1. Current use of prescribed or over-the-counter sleep medications.
2. Pregnant or lactating mother.
3. Current unusual or highly unstable sleep schedule
4. Trans-meridian travel across more than three time zones within 4
weeks prior to study entry.
5. Significant and uncontrolled major illness or psychiatric disease
6. Current life stress.
7. Use of tobacco within 6 months prior to study entry
8. Excessive use of alcohol or caffeine.
9. Currently taking hormone replacement therapy hypnotic or
psychotropic medication. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in sleep latency.
Improvement in sleep quality |
Visit 1 visit 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in sleep quality |
Visit 1 visit 2 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/11/2022 |
| Date of Study Completion (India) |
02/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
All the subjects having problems initiating or maintaining sleep will be enrolled in the study. Following laboratory tests will be performed to assess the safety of the investigational product. • CBC • Liver Profile • Lipid Profile • Kidney Profile • Fasting Blood sugar • Urine analysis • Pregnancy test Subjects will be assessed at screening and at the end of the study to know the safety of the product. During these visits all the above tests will be performed except pregnancy test at screening. Subjects who are eligible for the study will be enrolled in the study. Subjects will be asked to take ‘Sleep/well’ capsule an hour before going to bed. Subjects will be provided a diary to document every morning regarding their experience about sleep within 60 minutes from the consumption of the capsules, whether feeling groggy in the morning and more energized (no drowsiness) after waking up and better sleep quality through the night. Subjects will be assessed by Pittsburgh Sleep Quality Instrument (PSQI) score during screening and end of the study. |