| CTRI Number |
CTRI/2022/09/045855 [Registered on: 26/09/2022] Trial Registered Prospectively |
| Last Modified On: |
24/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of LN22197 in healthy subjects with sleep disturbance due to mild to moderate musculoskeletal discomfort |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled clinical study to assess the efficacy of LN22197 in healthy subjects with sleep disturbance due to mild to moderate musculoskeletal discomfort. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LN/NP/LN22197/22 Version 01, Dated 14-Apr-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Prason Kumar |
| Designation |
Overall Trial Coordinator |
| Affiliation |
Laila Nutraceuticals |
| Address |
40-15-14,First Floor,R&D Division,Clinical Research Department,Brindavan colony, Labbipet,Vijayawada
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
08662464445 |
| Fax |
08662475278 |
| Email |
prason@lailanutra.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Golakoti Trimurtulu |
| Designation |
Senior Vice-president-Technical |
| Affiliation |
Laila Nutraceuticals |
| Address |
Ground Floor, R&D Division, Survey No. 181/2,181/3,181/4B, JRD Tata Industrial Estate, Kanur,Vijayawada
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666636666 |
| Fax |
08662546216 |
| Email |
drgt@lailanutra.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Prason Kumar |
| Designation |
Manager-Clinical Research |
| Affiliation |
Laila Nutraceuticals |
| Address |
40-15-14,First Floor,R&D Division,Clinical Research Department,Brindavan colony, Labbipet,Vijayawada
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
08662464445 |
| Fax |
08662475278 |
| Email |
prason@lailanutra.in |
|
|
Source of Monetary or Material Support
|
| Laila Nutraceuticals Internal funding, 40-15-14, Brindavan colony, Labbipet, Vijayawada, Krishna, Andhra Pradesh- 520010 |
|
|
Primary Sponsor
|
| Name |
Laila Nutraceuticals |
| Address |
40-15-14, Brindavan Colony, Labbipet, Vijayawada, Krishna, Andhra Pradesh-520010,India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V Koteshwara Prasad |
Renova Neelima Hospitals |
7-2-1735 Opp: Voltas company Pvt Ltd,
Sanath Nagar, Hyderabad, Telangana-500018
Hyderabad
TELANGANA |
08019151935
koteshwaraprasad978@gmail.com |
| Dr Y Raviteja |
Samishta Hospital & Research Institute |
Donka Road, opposite 4th Line Arundelpet,
Guntur, Andhra Pradesh 522002
Guntur
ANDHRA PRADESH |
09848620890
inquest.cr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -Samishta Hospital & Research Institute for Dr Y Raviteja |
Approved |
| Institutional Ethics Committee- Renova Neelima Hospitals for Dr V Koteshwara Prasad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Night pain-related sleep disturbance |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: LN22197, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 300(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: NIL | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 300(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: NIL |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy male and female subjects aged between 40-70 years with a Body Mass Index –BMI of 20 to 29 kg per metre square.
2.Subjects with self-reported disturbed sleep due to musculoskeletal discomfort, and scoring less than or equal to 60 on Restorative Sleep Questionnaire-RSQ-W.
3.Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and or bilateral oophorectomy.
4.Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
5.Subjects agree to discontinue or not use supplements including vitamins and minerals, herbals or any other topical applications at least 15 days before screening visit, and for the duration of the study.
6.Subject agrees to complete the Consensus Sleep Diary daily upon waking.
7.Subjects agree to participate in the study through a written informed consent.
8.Subject willing to refrain from caffeine consumption in the 5 hour before their regular bedtime.
9.Subject agrees to not wear or use any sleep tracking devices i.e. FitBit, Garmin, Oura, Apple or Android smart watches or apps for the duration of the study.
10.Subject agrees to not take acetaminophen/paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever-OTC or prescription- or any herbal products for the duration of the study.
11.Subjects willing to comply with all the study related assessments and activities.
12.Willing to maintain current diet and activity level.
|
|
| ExclusionCriteria |
| Details |
1.Subjects having post COVID symptoms or underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
2.Subjects suffering from severe intrinsic sleep-related disorders such as sleep apnea, restless leg syndrome -RLS, narcolepsy.
3.Subjects having taken any sleep medication in the prior 6 months.
4.Subjects suffering from COPD or having history of any respiratory or breathing disorders.
5.Subjects who are diabetic-FBG greater than or equal to 126 mg per dl and or hypertensive-BP- Systolic greater than 145 mmHg and Diastolic greater 90 mmHg or need to take drug for diabetes or hypertension as per PIs opinion.
6.Subjects with any musculoskeletal injury in the last 3 months or surgery in prior 6 months.
7.Subjects used any immunosuppressive drugs in the last 6 months including steroids or biologics and those with history of immune system and autoimmune disorders.
8.Subjects with diagnosed osteoarthritis, rheumatoid arthritis or fibromyalgia.
9.Female subjects, who are pregnant, breastfeeding or planning to become pregnant during the study period.
10.Subjects with known allergy to non-steroidal anti-inflammatory drugs-NSAIDs including aspirin or has a suspected hypersensitivity, allergy or sensitivity to herbal products.
11.Subjects with history of congestive heart failure or any vascular conditions.
12.Subjects with HIV Positive status.
13.Evidence or history of clinically significant-in the judgment of the Investigator hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
14.Alcohol intake greater than two standard drinks per day or use of recreational drugs such as cocaine, methamphetamine, marijuana, etc.
15.Subjects currently suffering from depression or anxiety.
16.Subjects with any lifestyle factors that might be potentially associated with sleep problems such as excessive caffeine intake, shift work, and long distance traveling, or significant stressors, such as active grieving.
17.Subjects who regularly consume more than three cups of coffee or the equivalent in energy drinks.
18.Subjects with history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
19.Participation in any other trials involving investigational or marketed products within thirty days prior to the screening visit.
20.Have taken acetaminophen or paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever-OTC or prescription or any herbal products within seven days prior to the screening visit -visit 1.
21.History of heart, liver, lung cancer or chronic diseases.
22.Subjects allergic to any ingredient of the study investigational products.
23.Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures.
|
|
|
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 |
Change from baseline to the end of the study period in:
Nighttime pain (100mm VAS)
|
Day 1, Day 7, Day 14 and Day 28
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline to the end of the study period in:
Daytime pain assessment using Visual analog scale (100mm VAS)
|
Day 1, Day 7, Day 14 and Day 28 |
Change from baseline to the end of the study period in:
Restorative Sleep Questionnaire – weekly (RSQ-W) |
Screening, Day 1, Day 7, Day 14 and Day 28 |
Change from baseline to the end of the study period in:
Leeds Sleep Evaluation Questionnaire (LSEQ) |
Day 1, Day 7, Day 14 and Day 28
|
Change from baseline to the end of the study period in:
Mood assessment (using POMS-SF scale) |
Day 1, Day 7, Day 14 and Day 28 |
Change from baseline to the end of the study period in:
Consensus Sleep Diary – modified (CSD-M) completed daily upon waking
|
Day 1, Day 7, Day 14 and Day 28 |
Change from baseline to the end of the study period in:
Inflammatory biomarkers (Hs-CRP and TNF-α) |
Day 1, Day 7 (Only hs-CRP) and Day 28 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2022 |
| Date of Study Completion (India) |
08/02/2023 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to assess the efficacy of LN22197 in healthy subjects with sleep disturbance due to mild to moderate musculoskeletal discomfort. A total of 60 male and female subjects of age between 40 and 70 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer generated randomization list. The subjects will be assigned to either one of the two study groups (LN22197 300 mg or Placebo) at 1:1 ratio. The participants will be instructed to take one capsule daily after dinner for 28 days. The outcome measures include Nighttime pain (100mm VAS), Daytime pain assessment using Visual analog scale (100mm VAS), Restorative Sleep Questionnaire–weekly (RSQ-W), Leeds Sleep Evaluation Questionnaire (LSEQ), Mood assessment (using POMS-SF scale), Consensus Sleep Diary – modified (CSD-M) completed daily upon waking and Inflammatory biomarkers (Hs-CRP and TNF-α). Besides, the study will also record the vital signs and adverse events to evaluate the herbal composition’s safety and tolerability. The safety assessment of LN22197 will also include the routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention. |