| CTRI Number |
CTRI/2025/07/091819 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
efficacy of Shuddhi Dr. Sukoon Tablets in patients having Stress Issues. |
|
Scientific Title of Study
|
An open Label, Single arm Clinical Study to Evaluate the efficacy of Shuddhi Dr. Sukoon Tablets in patients having Stress Issues. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol Number 737 Version 1.0 15 May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raakhee Mehra |
| Designation |
Principal Investigator |
| Affiliation |
GS Ayurveda Medical College & Hospital Pilkhuwa Hapur |
| Address |
Ground floor, room no.2, Dept of General Medicine GS Ayurveda Medical College & Hospital Pilkhuwa Hapur
Meerut
UTTAR PRADESH
250002
India |
| Phone |
9868965688 |
| Fax |
|
| Email |
raakhimehra49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road, Meerut, UTTAR PRADESH-250005 |
| Jeena Sikho Lifecare Limited, Kalgidhar Enclave, Baltana, Zirakpur, Mohali Punjab 140604 |
|
|
Primary Sponsor
|
| Name |
Jeena Sikho Lifecare Limited |
| Address |
Kalgidhar Enclave, Baltana, Zirakpur, Mohali Punjab 140604 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raakhee Mehra |
GS Ayurveda Medical College & Hospital |
Ground floor, Room no.2, Dept of
General Medicine GS Ayurveda
Medical College & Hospital
Pilkhuwa Hapur.
Meerut
UTTAR PRADESH |
9868965688
raakhimehra49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GS Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F430||Acute stress reaction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product: Shuddhi Dr. Sukoon Tablets |
Dose: 1-1 Tablet (BD)
Route of Administration: Oral
Duration: 30 days.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject from 18-65 years of age.
2. Subject suffering from one or multiple mental health Issues from- anxiety, insomnia, mood disorder etc.
3. Subjects that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study.
4. Subject willing to avoid participation in any other interventional clinical trial for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids.
2. Subjects that have participated in any other interventional clinical trial in the previous 90 days.
3. Subjects with known sensitivity to any of the constituents of the investigational product.
4. Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
5. Chronic illness which may influence the outcome of the study.
6. Pregnant/nursing mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. SGA(Subject Global Assessment) score
2. EEG Score
3. Change in mental QOL Score (DASS-21).
|
Day 1, Day 15, Day30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
08/08/2025 |
| 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="1"
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
|
An open label single arm study. Each participant entering the trial will be assigned to a regimen of
investigational product, and advised to take general precautions as needed.
Patients will be assigned to investigational
product for 30days, following up on 1st and 15th and 30th day. Subject from 18-65 years Test Product: Shuddhi Dr. Sukoon Tablets Dose: 1-1 Tablet (BD) Route of Administration: Oral Duration: day 1st , 15th and 30th
ยท Perform the following assessments o SGA o EEG o QOL(DASS-21) |