Clinical study on AshwaDaatÂ® Capsule in subjects with Stress and Insomnia

Phase 2/3

Completed

Conditions: Insomnia, (2) ICD-10 Condition: Z733||Stress, not elsewhere classified,

Registration Number: CTRI/2020/11/028937

Lead Sponsor: LODAAT PHARMA

Brief Summary: It is an open label, multi center, non-comparative, interventional, prospective clinical study to evaluate efficacy and safety of AshwaDaatÂ® Capsule in subjects with Stress and Insomnia. The study will be conducted at two sites in India. Subjects will be advised to take AshwaDaatÂ® in a dose of 2 Capsules twice daily orally after meals with water for a period of 30 days. The primary objective of the study will be to assess **c**hanges in stress on perceived stress scale (PSS) over a period of one month. The secondary objectives of the study will be to assess changes in severity of Insomnia on Insomnia Severity Index, change in pre and post serum cortisol (morning) level, change in Quality of Life on GHQ28 Scale , changes in safety assessment parameters like vitals including blood pressure, pulse rate, respiration rate and body temperature, assessment of occurrence adverse event, global assessment for overall change by investigator and subject on CGI Scale, assessment of tolerability of study drug by investigator and subject, assessment of safety by assessing safety lab parameters.

**Results:**

There was statistically significant reduction in stress and insomnia with the use of AshwadaatÂ®. A significant improvement in sleep quality along with improvement of quality of life (QOL) was seen at day 15 and day 30 as compared to the baseline scores. There was a reduction in morning Serum cortisol levels (within normal range) from baseline to 30 days. Excellent tolerability was reported over 30 days of consumption of AshwadaatÂ®. There were no adverse effects due to the consumption of AshwadaatÂ® and also the safety related laboratory parameters were within the normal range at baseline and further at the end of the study.

**Conclusion:** AshwadaatÂ® was found to be effective in reduction of stress and other associated symptoms, also effective in improving sleep quality, quality of life, without producing any adverse effects.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.Subjects who perceive themselves to be under stress and having a score between 14 -24 on the Perceived Stress Scale (PSS) 2.Subjects not having any psychiatric conditions other than stress 3.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

Exclusion Criteria

1.Subjects suffering from any chronic physical, hormonal or psychiatric illness 2.Subjects on treatment for stress and insomnia 3.Subjects using oral or systemic contraceptive medications 4.Subjects with uncontrolled diabetes and hypertension 5.Subjects with substance dependence 6.
Chronic alcoholics and Habitual Tobacco chewers.
7.Known cases of Severe/Chronic hepatic or renal disease.
8.Known case of any active malignancy.
9.Subjects giving history of significant cardiovascular event < 12 weeks prior to recruitment.
10.Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
11.Known case of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
12.Subjects using any other investigational drug within 1 month prior to recruitment or Subjects currently participating in any other Clinical study 13.Known hypersensitivity to any of the ingredients used in study drug 14.Pregnant and Lactating females.
15.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
Changes in stress on perceived stress scale (PSS)	Day -3, Day 0, Day 15, Day 30

Secondary Outcome Measures

Name	Time	Method
1.Changes in severity of Insomnia on Insomnia Severity Index	2.Change in pre and post serum cortisol (morning) level

Trial Locations

Locations (2): D. Y. Patil University, School of Ayurveda, Nerul
🇮🇳
(Suburban), MAHARASHTRA, India
KVTR Ayurvedic College Boradi
🇮🇳
Dhule, MAHARASHTRA, India
D. Y. Patil University, School of Ayurveda, Nerul
🇮🇳(Suburban), MAHARASHTRA, India
Dr Maheshkumar Harit
Principal investigator
9322217607
drmaheshkharit@rediffmail.com