| CTRI Number |
CTRI/2020/11/028939 [Registered on: 05/11/2020] Trial Registered Prospectively |
| Last Modified On: |
26/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Tulsi Odaat® Capsule in Sleep Disorder |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of Tulsi Odaat® Capsule in patients suffering from Insomnia Disorder- An Open Label, Single arm, Multi-centric, Non- comparative, Interventional, Prospective, Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TUL/LODAAT/2020/ Version 1.0, 7th October 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maheshkumar Harit |
| Designation |
Dean |
| Affiliation |
D. Y. Patil University School of Ayurveda |
| Address |
OPD No.10 Ground Floor, Department of Kayachiktsa D. Y. Patil University School of Ayurveda Nerul, Sector 1 Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9322217607 |
| Fax |
|
| Email |
drmaheshkharit@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| LODAAT PHARMA
1415 West 22nd Street-Tower Floor,
Oak Brook, Illinois 60523 |
|
|
Primary Sponsor
|
| Name |
LODAAT PHARMA |
| Address |
1415 West 22nd Street-Tower Floor, Oak Brook, Illinois 60523
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shishir Pande |
Ayurved Seva Sangh’s Ayurved Mahavidyalaya |
OPD No 7A, Ground Floor, Ayurved Sanshodhan Vibhag, Ayurved Seva Sanghs Ayurved Mahavidyalaya, Ganeshwadi, Panchvati, Nashik – 422003
Nashik
MAHARASHTRA |
9420830818
shishir.nsk@gmail.com |
| Dr Maheshkumar Harit |
D. Y. Patil University, School of Ayurveda, Nerul |
OPD No.10 Ground Floor, Department of Kayachiktsa D. Y. Patil University School of Ayurveda Nerul, Sector 1 Navi Mumbai 400706
Mumbai (Suburban)
MAHARASHTRA |
9322217607
drmaheshkharit@rediffmail.com |
| Dr Shailesh Deshpande |
Parul Ayurveda Hospital, Parul University |
Department of Kaychikitsa, OPD no 106, Ground Floor, Parul Ayurveda Hospital, Parul University, P.O.Limba, Tal. Wagholia, Dist, Vadodara, Gujrat 391760
Vadodara
GUJARAT |
9763104451
dr.shaileshd@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee –D Y Patil University, School of Ayurveda, Nerul, Mumbai |
Approved |
| Institutional Ethics Committee on Human Research,(PIA-IECHR) |
Approved |
| Institutional Ethics Committee, Ayurved seva sangh Ayurved Mahavidyalaya, Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Tulsi Odaat® Capsule |
Contains Tulsi 2.5% Extract (Ocimum sanctum) and Ursolic acid
Dosage and Treatment Duration: 1 Capsule twice daily orally after meals with water for a period of 28 days.
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects diagnosed with Insomnia Disorder based on DSM-5 Diagnostic Criteria for Insomnia Disorder
2. Insomnia Severity Index more than 7 and less than 21
3. Subjects willing to sign inform consent form
4. A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period
5. Willing to stop alcohol, caffeine, and nicotine consumption while in the study
|
|
| ExclusionCriteria |
| Details |
1. History or diagnosis of any other disease resulting in another sleep disorder
2. History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder or current psychiatric disorder that requires medication
3. On-going depression and generalized anxiety disorder
4. History of substance abuse or dependence
5. History or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ECG) at screening visit
6. Taking prohibited medications [opium, cannabis (marijuana) and methamphetamines]
7. Subjects with habit of smoking
8. Subjects with known history of hepatitis B and/ or C
9. History of malignancy ≤5 years prior to study participation
10. Known hypersensitivity to any of the ingredients of “Tulsi Odaat® Capsuleâ€
11. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in patient-reported total sleep time (as per patient diary)
2. Change in sleep efficiency
|
Day-3, Day 0, Day 14, Day 28, Day 35 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in patient-reported time to sleep onset, number of awakenings and WASO
2. Requirement of sedatives as rescue medication
3. Change in severity of Insomnia
4. Changes in daytime fatigue, mood, ability to function at work, concentration and memory
5. Assessment of Quality of sleep on PSQI and rebound of insomnia
6. Global assessment for overall change by investigator and by patient
7. Assessment of tolerability of study drug, adverse events, vitals and safety lab parameters
|
Day-3, Day 0, Day 14, Day 28, Day 35 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/11/2020 |
| Date of Study Completion (India) |
Date Missing |
| 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
Modification(s)
|
Paper published in International Journal For Research In Applied And Natural Science (Aug-2021) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is an open label, single arm, multi-centric, non- comparative, interventional, prospective, clinical study to evaluate efficacy and safety of Tulsi Odaat® Capsule in patients suffering from Insomnia Disorder. The study will be conducted at three sites in India. Subjects will be advised to take Tulsi Odaat® in a dose of 1 Capsule twice daily orally after meals with water for a period of 28 days. The primary objectives of the study will be to assess change in patient-reported total sleep time (as per patient diary) and change in sleep efficiency (Total sleep time/ time in bed*100) derived from patient diary. The secondary objectives of the study will be to assess change in patient-reported time to sleep onset, change in patient- reported number of awakenings, change in patient -reported wake time after sleep onset, requirement of sedatives as rescue medication during study period, change in severity of Insomnia using Insomnia Severity Index, change in daytime fatigue using Fatigue Severity Scale (FSS), changes in daytime mood, ability to function at work, concentration and memory on a graded scale, assessment of rebound of insomnia on day 35, quality of sleep on Pittsburgh Sleep Quality Index (PSQI), global assessment for overall change by investigator and by patient at the end of the study treatment, assessment of tolerability of study drug by investigator and subject at the end of treatment and assessment of safety by assessing, adverse events, vitals and safety lab parameters.
Results and Conclusion:
It can be
concluded from the results that TulsiOdaatâ„¢ botanical ingredient extract is
safe and effective in subjects suffering from primary insomnia. TulsiOdaatTM
significantly improved total sleep time and sleep efficiency in subjects
suffering from mild to moderate insomnia. TulsiOdaatTM significantly
reduced time
to sleep onset, the total number of awakenings, wake time after sleep onset and
severity of insomnia. The significant effect of TulsiOdaatTM in
primary insomnia started after 7 days of treatment and continued until the end
of the study. TulsiOdaatâ„¢ significantly improves symptoms associated with
primary insomnia such as fatigue, problems in daytime mood, ability to function
at work, concentration, and memory. TulsiOdaatTM also significantly
improves the quality of sleep in subjects suffering from insomnia. Even after
stoppage of treatment for seven days, no significant rebound of insomnia was
observed in any of the subjects suffering from primary insomnia. Thus, it can
be concluded that TulsiOdaatâ„¢ is safe and effective for the
treatment of primary insomnia. Further comparative studies with larger sample
size are warrented to validate and confirm on the clinical efficacy as well as
mode of action of TulsiOdaatâ„¢.
|