| CTRI Number |
CTRI/2020/11/028937 [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 AshwaDaat® Capsule in subjects with Stress and Insomnia |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of AshwaDaat® Capsule in subjects with Stress and Insomnia – An Open label, multi center, non-comparative, interventional, prospective clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ASH/LODAAT/2020/ Version 1.0, 2nd 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
Room No. 402 A, 4th Floor, A wing 402 A/B/C, Jaswanti Allied Business Center, 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
Room No. 402 A, 4th Floor, A wing 402 A/B/C, Jaswanti Allied Business Center, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| 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 Narendra B Mundhe |
KVTR Ayurvedic College Boradi |
Department of Kayachikitsa,
OPD No. 5, Ground Floor, Department of Kayachikitsa, KVTR Ayurvedic College Boradi, Tal. Shirpur, Dist. Dhule-425428
Dhule
MAHARASHTRA |
9850378206
drnbmundhe@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee –D Y Patil University, School of Ayurveda, Nerul, Mumbai |
Approved |
| Institutional Ethics Committee, KVTR Ayurvedic College Boradi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, (2) ICD-10 Condition: Z733||Stress, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AshwaDaat® Capsule |
Contains Ashvagandha (Withania somnifera) Root Extract (Standardized to Withenoloids NLT 5%) and Marich (Piper nigrum) Fruit Extract
Dosage and Treatment Duration: 2 Capsules twice daily for a period of 30 days
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in stress on perceived stress scale (PSS) |
Day -3, Day 0, Day 15, Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in severity of Insomnia on Insomnia Severity Index
2. Change in pre and post serum cortisol (morning) level
3. Change in Quality of Life on GHQ28 Scale
4. Changes in vitals.
5. Assessment of occurrence adverse event
6. Global assessment for overall change by investigator and subject on CGI Scale
7. Assessment of tolerability of study drug by investigator and subject.
8. Assessment of safety by assessing safety lab parameters
|
Day -3, Day 0, Day 15, Day 30 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
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 (April 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, multi center, non-comparative, interventional, prospective clinical study to evaluate efficacy and safety of AshwaDaat® Capsule in subjects with Stress and Insomnia. The study will be conducted at two sites in India. Subjects will be advised to take AshwaDaat® 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 changes 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 Ashwadaat®. 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 Ashwadaat®. There were no adverse effects due to the consumption of Ashwadaat® and also the safety related laboratory parameters were within the normal range at baseline and further at the end of the study.
Conclusion: Ashwadaat® 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.
|