Clinical study on Tulsi Odaat® Capsule in Sleep Disorder

Phase 2/3

Completed

• Conditions: Insomnia,

• Registration Number: CTRI/2020/11/028939
• Lead Sponsor: LODAAT PHARMA

Brief Summary

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 beconcluded from the results that TulsiOdaatâ„¢ botanical ingredient extract issafe and effective in subjects suffering from primary insomnia. TulsiOdaatTMsignificantly improved total sleep time and sleep efficiency in subjectssuffering from mild to moderate insomnia. TulsiOdaatTM significantlyreducedtimeto sleep onset, the total number of awakenings, wake time after sleep onset andseverity of insomnia. The significant effect of TulsiOdaatTM inprimary insomnia started after 7 days of treatment and continued until the endof the study. TulsiOdaatâ„¢ significantly improves symptoms associated withprimary insomnia such as fatigue, problems in daytime mood, ability to functionat work, concentration, and memory. TulsiOdaatTM also significantlyimproves the quality of sleep in subjects suffering from insomnia. Even afterstoppage of treatment for seven days, no significant rebound of insomnia wasobserved in any of the subjects suffering from primary insomnia. Thus, it canbe concluded that TulsiOdaatâ„¢is safe and effective for thetreatment of primary insomnia. Further comparative studies with larger samplesize are warrented to validate and confirm on the clinical efficacy as well asmode of action of TulsiOdaatâ„¢.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-11
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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.

Exclusion Criteria

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® Capsule†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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in patient-reported total sleep time (as per patient diary)	Day-3, Day 0, Day 14, Day 28, Day 35
2.Change in sleep efficiency	Day-3, Day 0, Day 14, Day 28, Day 35

Secondary Outcome Measures

Name	Time	Method
1.Change in patient-reported time to sleep onset, number of awakenings and WASO	2.Requirement of sedatives as rescue medication

Trial Locations

Locations (3)

Ayurved Seva Sangh’s Ayurved Mahavidyalaya; 🇮🇳 Nashik, MAHARASHTRA, India

D. Y. Patil University, School of Ayurveda, Nerul; 🇮🇳 (Suburban), MAHARASHTRA, India

Parul Ayurveda Hospital, Parul University; 🇮🇳 Vadodara, GUJARAT, India

Ayurved Seva Sangh’s Ayurved Mahavidyalaya

🇮🇳Nashik, MAHARASHTRA, India

Dr Shishir Pande

Principal investigator

9420830818

shishir.nsk@gmail.com