| CTRI Number |
CTRI/2018/04/012984 [Registered on: 03/04/2018] Trial Registered Prospectively |
| Last Modified On: |
29/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Study on Ayumem Capsule in Stress and Insomnia. |
|
Scientific Title of Study
|
A Randomized, Double blind, Placebo controlled, Multi-centric, Interventional, Prospective Clinical study to Evaluate Efficacy and Safety of Ayumem Capsule in subjects with Stress and Insomnia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AYUMEM/SI/WELX/2018, Version 1.0, 15th Mar 2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narendrakumar Bhanudas Mundhe |
| Designation |
Assistant Professor |
| Affiliation |
KVTR Ayurvedic College & Hospital Boradi |
| Address |
Department of Kayachikitsa Kayachikitsa OPD Ground Floor KVTR Ayurvedic Collage and Hospital Boradi Tal Shirpur, Dist Dhule
Dhule
MAHARASHTRA
425428
India |
| Phone |
9850378206 |
| Fax |
|
| Email |
drnbmundhe@gmail.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
205, B Wing, Blue Diamond Society, Nayagoan, Dahisar West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400068
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vandana Bade |
| Designation |
Manager - Clinical Trial Operation |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
205, B Wing, Blue Diamond Society, Nayagoan, Dahisar West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400068
India |
| Phone |
8149507065 |
| Fax |
|
| Email |
vandana@targetinstitute.in |
|
|
Source of Monetary or Material Support
|
| Welex Laboratories Pvt. Ltd.
1002, Marathon Innova Nextgen,
Off Ganpatrao kadam marg,
Lower Parel, Mumbai -13
|
|
|
Primary Sponsor
|
| Name |
Welex Laboratories Pvt Ltd |
| Address |
1002, Marathon Innova Nextgen,
Off Ganpatrao kadam marg,
Lower Parel, Mumbai -13
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Narendrakumar B Mundhe |
KVTR Ayurvedic College and Hospital Boradi |
KVTR Ayurvedic College BoradiOPD No 5 Ground Floor Department of Kayachikitsa KVTR Ayurvedic College Boradi Tal Shirpur Dist Dhule 425428
Dhule
MAHARASHTRA |
9850378206
drnbmundhe@gmail.com |
| Dr Vijayendra Bhat |
S.D.M. College of Ayurveda, Kuthpady,Udupi |
P.G.Department of
Kayachikitsa and Manasaroga, OPD NO. 7, Ground Floor, S.D.M. College of Ayurveda,
Kuthpady Udupi -574 118
Udupi
KARNATAKA |
9448353813
gsa.ayurved@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Clearance committee –Human,Laxminarayana Nagar,P.O.Kuthpady,Dist-Udupi |
Approved |
| KVTR Ayurvedic College, Boradi, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Stress and Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ayumem Capsule |
It Contains Centella asiatica, Convolvulus pluricaulis, Withania somnifera, Glycerrhiza glabra, Asparagus racemosus, Celastrus paniculatus.
Dosage and Treatment Duration: Ayumem 2 Capsules twice daily orally after meals with lukewarm water for 60 days.
|
| Comparator Agent |
Placebo Capsule |
Dosage and Treatment Duration: 2 Capsules twice daily orally after meals with lukewarm water for 60 days. |
|
|
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 of between 14 -24 on the Perceived Stress Scale (PSS).
2.Subjects not having any other psychiatric conditions 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 using oral or systemic contraceptive medications.
3. Subjects with uncontrolled diabetes and hypertension.
4. Subjects with substance dependence.
5. Chronic alcoholics and Habitual Tobacco chewers.
6. Known cases of Severe/Chronic hepatic or renal disease.
7. Known subject of any active malignancy.
8. Subjects giving history of significant cardiovascular event <12 weeks prior to recruitment.
9. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
10. Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
11. Subjects using any other investigational drug within 1 month prior to recruitment or Subjects currently participating in any other Clinical study.
12. Known hypersensitivity to any of the ingredients used in study drug.
13. Pregnant and Lactating females.
14. 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
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of Ayumen Capsules on stress using perceived stress scale (PSS) in comparison to placebo
|
Day-3, Day 0, Day 30, Day 60
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of Ayumem Capsules on stress using perceived stress scale
2. Assessment of severity of Insomnia on Insomnia Severity Index.
3. Assessment of pre and post serum cortisol (morning).
4. Assessment of Quality of Life on GHQ28 Scale.
5. Assessment on vitals and adverse event.
6. Global assessment for overall change by investigator and Subject.
7. Assessment of tolerability of study drugs by investigator and subject.
8. Assessment of lab parameters
|
Day-3, Day 0, Day 30, Day 60
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "61"
Final Enrollment numbers achieved (India)="61" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/04/2018 |
| Date of Study Completion (India) |
11/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet Done |
|
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 a randomized, double blind, placebo controlled, multi-centric, interventional, prospective clinical study to evaluate efficacy and safety of Ayumem Capsule in subjects with Stress and Insomnia. The study will be conducted at two sites in India. As per computer generated randomization list, subjects will be advised to take either study product or placebo in the dose of 2 capsules twice daily for a period of 60 days. The primary objective will be assessment of Ayumen Capsules on stress using perceived stress scale (PSS) in comparison to placebo from baseline to 60 days. The secondary objectives will be assessment of Ayumem Capsules on stress using perceived stress scale, assessment of severity of Insomnia on Insomnia Severity Index, assessment of pre and post serum cortisol (morning), assessment of Quality of Life on GHQ28 Scale, assessment on vitals and adverse event, global assessment for overall change by investigator and Subject, assessment of tolerability of study drugs by investigator and subject, and assessment of lab parameters |