| CTRI Number |
CTRI/2022/07/043761 [Registered on: 06/07/2022] Trial Registered Prospectively |
| Last Modified On: |
11/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Study to evaluate the Safety and Efficacy of KaraCalmTM - to manage stress and improve sleep in adults |
|
Scientific Title of Study
|
A Randomized, Double Blind, Parallel, Placebo Controlled Study to evaluate the Safety and Efficacy of KaraCalm - a dietary supplement to manage stress and improve sleep in adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GC/KCM/0322 version 1.0 Dated 15 march 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish Kumar Gupta |
| Designation |
Pyschiatrist |
| Affiliation |
Vatsalya Hospital |
| Address |
Department of Psychiatry, Room no 3 First Floor S2 656C 4A Sikraul
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9838602582 |
| Fax |
|
| Email |
Ashishkgmcbhu07@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Abhinav Shukla |
| Designation |
Project Manager |
| Affiliation |
Ayurlife health solutions |
| Address |
#10/1, 13th Main Road, Ground Floor, Room #1, Srinagar
Bangalore Rural
KARNATAKA
560050
India |
| Phone |
7019546868 |
| Fax |
|
| Email |
abhinavshukla.ayurlife@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Abhinav Shukla |
| Designation |
Manager |
| Affiliation |
Ayurlife health solutions |
| Address |
#10/1, 13th Main Road, Ground Floor, Room #1, Srinagar
Bangalore Rural
KARNATAKA
560050
India |
| Phone |
7019546868 |
| Fax |
|
| Email |
abhinavshukla.ayurlife@gmail.com |
|
|
Source of Monetary or Material Support
|
| Green Chem, 2030, 1st Cross Rd, HAL 2nd Stage, Kodihalli |
|
|
Primary Sponsor
|
| Name |
Green Chem |
| Address |
2030, 1st Cross Rd, HAL 2nd Stage, Kodihalli, Bengaluru, Karnataka 560008 |
| Type of Sponsor |
Other [Nutraceutical] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish Kumar Gupta |
Vatsalya Hospital |
Department of Psychiatry, Room no 3 First Floor S2 656C 4A Sikraul
S2 656C 4A Sikraul
Varanasi
UTTAR PRADESH |
9415227170
Ashishkgmcbhu07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vatsalya Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: NIDRANASAH/ASVAPNAH, (2) ICD-10 Condition:G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: OJAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: KaraCalm, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: -), Additional Information: Participants will be administered one capsule a day for 56 days | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: Participants will be administered one capsule a day for 56 days |
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
54.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and Female healthy adult subjects ranging in age from 18 to 54 years.
2.Adults Subjects willing to provide a written Informed Consent
3.Free of psychiatric conditions other than mild stress
4.Could read and write English.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with insomnia, sleep disorders, or chronic stress
2.Chronic alcoholics (more than 2 standard pegs / day)
3.Subjects with known Hypertension and other diseases of the cardiovascular system
4.Subjects with known Liver diseases, Kidney diseases, Psychiatric diseases, Epilepsy and/or with any other relevant diseases
5.Subjects with the intention of non-compliance to the study-protocol
6.Subject participating in another clinical trial or has received any IP within 90 days prior to Visit 1 (Screening).
7.Retraction of the written informed consent
8.Subjects currently taking medications other than oral contraceptive pill
9.Participants on hepatotoxic medications like antitubercular medication, antiviral medication, paracetamol etc.
10.Pregnant, attempting to conceive, or lactating women
11.Individuals with acute narrow-angle glaucoma, prostate hypertrophy, cardiovascular, endocrine or renal disease, or another chronic disease that could affect stress/anxiety or restrict normal, daily function were also ineligible to participate in the study.
12.Individuals who currently, or in the past 6 months, suffered from any diagnosable mental-health disorder (as assessed by the Mini International Neuropsychiatric Interview 6.0) or were taking a psychotropic medication or other herbal preparation were also excluded from participating in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline - Sleep analysis by using Acti Watch |
Baseline, Day 14 and Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to the end of the study in Perceived Stress Scale |
Screening, Baseline, Day 14, 28, & 56 |
| Change from baseline to the end of the study in Athens Insomnia Scale |
Screening, Baseline, Day 14, 28, & 56 |
| Change from baseline to the end of the study in Serum Cortisol |
Baseline, Day 14 and Day 56 |
| Change from baseline to the end of the study in Hs CRP |
Baseline, Day 14 and Day 56 |
| To assess the Safety and Tolerability of IP |
Baseline and Day 56 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/07/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="4" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
is a randomized, placebo controlled double blind clinical study to evaluate the
Safety and efficacy of a dietary supplement (KaraCalm) - to manage Stress and
improve Sleep in adults. All
subjects will receive either Test or Reference product for a period of 56 days.
The efficacy parameters will be analyzed on Baseline, Day 14, Day 28 and Day 56.
|