| CTRI Number |
CTRI/2024/04/065842 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Phase IV, Clinical Study to Evaluate Safety and Efficacy of My V3 Ayurvedic Capsules in Healthy Participants.
|
|
Scientific Title of Study
|
A Single Center Prospective Open Label Phase IV Clinical Study to Evaluate Safety and Efficacy of My V3 Ayurvedic Capsules in Healthy Participants.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VH-MY-001-24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MS Ramasamy |
| Designation |
Principal Investigator |
| Affiliation |
Sanjeev Biomedical Research Center |
| Address |
Sanjeev Biomedical Research Center 1/15, Kumaran, Street,
Keelkatalai, Chennai-600 117, Tamil Nadu, India
Chennai
TAMIL NADU
600117
India |
| Phone |
9176049309 |
| Fax |
|
| Email |
ramasamy.mani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MS Ramasamy |
| Designation |
Principal Investigator |
| Affiliation |
Sanjeev Biomedical Research Center |
| Address |
Sanjeev Biomedical Research Center 1/15, Kumaran Street,
Keelkatalai, Chennai-600 117, Tamil Nadu, India
Chennai
TAMIL NADU
600117
India |
| Phone |
9176049309 |
| Fax |
|
| Email |
ramasamy.mani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MS Ramasamy |
| Designation |
Principal Investigator |
| Affiliation |
Sanjeev Biomedical Research Center |
| Address |
Sanjeev Biomedical Research Center 1/15, Kumaran, Street,
Keelkatalai, Chennai-600 117, Tamil Nadu, India
Chennai
TAMIL NADU
600117
India |
| Phone |
9176049309 |
| Fax |
|
| Email |
ramasamy.mani@gmail.com |
|
|
Source of Monetary or Material Support
|
| M/S. VEE HERBAL CARE PVT LTD, No:24, Rajagowri Nagar, Koravallimedu, MadhiKrishna Puram Puducherry- 607402 |
|
|
Primary Sponsor
|
| Name |
M/S. VEE HERBAL CARE PVT LTD |
| Address |
No. 24, Rajagowri Nagar Koravallimedu, Mathikrishnapuram, Puducherry-607402 |
| Type of Sponsor |
Other [] |
|
|
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 ChikkalingaiahS MD |
Aarupadai Veedu Medical College |
Room- Clinical Research Unit, Ground floor, Commune Panchayat,
Pondy Cuddalore Main
Road,
Kirumampakkam,
Puducherry 607402.
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY |
9538880387
medstarclinicalresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medstar Specilaity Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Participants
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
1) Male/females of greater than or equal to 18 years of age at the time of consent
2)Patient / Legally Acceptable
Representative who can and willing to provide Informed Consent
3)Confirmed anemia
4)Clinically stable for at least 1 month prior to entry into the study
5)Score on the Insomnia Severity Index (ISI) measure greater than or equal to 15 |
|
| ExclusionCriteria |
| Details |
1)Pregnant or lactating women or women of childbearing potential who did not use oral contraceptives or an intrauterine device.
2)Administration of another investigational drug within 1 month before screening or planned during the study period.
3) Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
4) Diagnosis of other primary sleep disorders
5) Psychotherapy within the past six months
6) Shift workers
7) Current or expected use of hypnotic medications
8) Renal or hepatic disease
9) History of Neurological disorder or cardiovascular disease raising safety concerns
10) Excessive coffee or cigarette use
11) Recent surgery
12) Current alcohol/substance use disorder
13) Current major depressive episode |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in the Immune Status Questionnaire (ISQ) from baseline to end of the study
2.Improvement in Hemoglobin level from baseline to end of the study |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in the Liver function test (LFT)Parameters.
2.Improvement in the (Pittsburgh Sleep Quality
Index PSQI) from base line to end of the study.
3.Number of Treatment Emergent Adverse Event(TEAE) and Treatment Emergent Serious
Adverse Event (TESAE) |
2 months |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
28/05/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
My V3 Ayurvedic capsules are food supplements derived from the combination of carefully selected herbs, which is a source of immunity in the daily consumption. This food supplement has a therapeutic effect of the ingredients like ThuthiVidhai, Thannervittan, Vembu, Beetroot, Vallarai, Musli, Aragampul, Amla, Liqorice, Murungai, Thetraakottai, Triphala, Aswagandha. The ingredients have the effect of improving immunity, General health, can be effective for people who are Anemic, Insomnia and also helps in stress management |