| CTRI Number |
CTRI/2025/07/090292 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check the safety and efficacy of Cread AM on the adult participants with mild stress and anxiety. |
|
Scientific Title of Study
|
A Non Randomized Single Arm Study to Evaluate the Safety and Efficacy
of Cread AM an Ayurvedic Formulation to Manage Stress and Anxiety in Adults |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geetha L |
| Designation |
MD (Manasaroga -Psychiatry) |
| Affiliation |
Ayuryog Ayurvedic Centre |
| Address |
Ayuryog Ayurvedic Centre,
#1964/1, 20th Main, 7th Cross, JP Nagar, 2nd Phase, Bangalore-560078
Bangalore
KARNATAKA
560078
India |
| Phone |
7204755902 |
| Fax |
|
| Email |
geetha8jaiswal@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Hasan Ali Ahmed |
| Designation |
Director |
| Affiliation |
Xplora Clinical Research Services Pvt Ltd |
| Address |
#252, 13th Cross, Wilson Garden,Bangalore-560027
Bangalore
KARNATAKA
560027
India |
| Phone |
9886012598 |
| Fax |
|
| Email |
hasan@xplorahealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Manik Chaudari |
| Designation |
Project Manager |
| Affiliation |
Xplora Clinical Research Services Pvt Ltd |
| Address |
#252, 13th Cross, Wilson Garden,Bangalore-560027
Bangalore
KARNATAKA
560027
India |
| Phone |
9738651205 |
| Fax |
|
| Email |
manik@xplorahealth.com |
|
|
Source of Monetary or Material Support
|
| Medisun Pharma pvt Ltd
P-39, MIDC Nanded, Balirampur, Maharashtra 431603 |
|
|
Primary Sponsor
|
| Name |
Medisun Pharma Pvt Ltd |
| Address |
P-39, MIDC Nanded, Balirampur, Maharashtra 431603 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Geetha L |
Ayuryog Ayurvedic Center |
#1964/ 20th Main, 7th Cross, JP Nagar, 2nd Phase, Bangalore-560078
Bangalore
KARNATAKA |
7204755902
geetha8jaiswal@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F489||Nonpsychotic mental disorder, unspecified. Ayurveda Condition: UNMADAH, (2) ICD-10 Condition:F488||Other specified nonpsychotic mental disorders. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Cread-AM, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 460(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female adults aged between 18 and 60 years.
2. Individuals presenting (at least 2 weeks) with mild to moderate stress and anxiety disorders as per DSM-V-TR Diagnostic Criteria and further fulfilling the following criteria:
A score 10-26 on the Perceived Stress Scale (PSS)
3. Women of child-bearing potential willing to use an adequate method of contraception to avoid pregnancy throughout the study period
4. Willing to sign inform consent document and abide by the study procedures. |
|
| ExclusionCriteria |
| Details |
1. Chronic alcoholics consuming more than 2 standard pegs per day.
2. Subjects with known hypertension or other
cardiovascular diseases diseases. However controlled case of hypertension with stable dosages medication can be enrolled in the study
3. Subjects with a history of liver diseases, kidney diseases, psychiatric conditions, epilepsy, or any other relevant medical conditions.
4. Subjects unwilling or unable to comply with the study protocol.
5. Subjects currently participating in another clinical trial or who have received any investigational product (IP) within 90 days prior to Visit 1 (Screening).
6. Subjects currently taking medications other than oral contraceptives.
7. Subjects on hepatotoxic medications, such as antitubercular medications, antiviral medications, or paracetamol.
8. Pregnant women, those attempting to conceive, or lactating women.
9. Individu als with acute narrow angle glaucoma, prostate hypertrophy, or any cardiovascular, endocrine, renal, or other chronic diseases that could influence stress or anxiety or restrict normal daily functioning.
10. Individuals with any diagnosable mental health
disor der in the past 6 months or those currently taking psychotropic medications or other herbal preparations. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the efficacy of Cread AM in improving Anxiety in Adults as measured by General Anxiety Disorder 7 (GAD 7) scale from Screening to the end of the study (assessments at Day 1 and Day 56).
2) To assess the efficacy of Cread AM in in managing stress levels in adults as measured by Perceived Stress Scale (PSS) scale from Screening to the end of the study (assessments at Day 1
and Day 56). |
Visit-1(Day-1), Visit-2(Telephonic), Visit-3(Day-56) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the impact of Cread AM on stress using Serum
Cortisol levels at Day 1 and Day 56
2) To monitor safety parameters at Day 1 to Day 56 for any adverse events or clinically significant findings
3) To assess the safety and tolerability of Cread AM throughout the study period by evaluating clinical and laboratory parameters. Measurements will be conducted at Screening and End of visit . |
Visit-1(Day-1), Visit-2(Telephonic), Visit-3(Day-56) |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Stress and anxiety are among the most prevalent mental helath concerns worldwide, significantly impacting quality of life, cognitive function, and overall well being. The administrtion of Cread AM , an Ayurvedic formulation is expected to provide significant benefits in managing stress and anxiety while maintaining favourable safety profile.The current study aim to evaluating the safety and efficacy of Cread AM in managing stress and anxiety. Primary objectives is to evaluate the efficacy of Cread AM in improving anxiety in adults as measured by GAD-7 scale from screening to end of visit and to assess the efficacy of Cread AM in managing stress levels in adults as measured by PSS scale from screening to end of visit. Secondary objectives is to evaluate the impact of Cread AM on stress using serum cortisol levels day-1 and day-56, to monitor safety parameters at day-1 to day-56 and to assess the safety and tolerability of Cread AM throughout the study period by evaluating clinical and laboratory parameters. The study will include 3 visits- Screening visit- Viist-1- Informed concent form, Demogarphic details, Medical history, General physical examination, Vital signs, Safety laboratory examinations, PSS and GAD-7 scores, Testproduct dispensing, Instructions for the next visit, Visit-2 -Telephonic Visit- Compliance of the testproduct, Instructions for the next visit and Visit-3- End of visit- General physical examination, Vital signs, PSS and GAD-7 scores, Compliance and retrival of the test product. Cread AM will be administered as 460mg capsule taken orally twice daily for a total duration of 56 days.
|