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CTRI Number  CTRI/2024/08/072589 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 06/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluate the effectiveness and safety of VHAKM-Akkermansia muciniphila in sleep, stress and cognition study 
Scientific Title of Study   A Randomized Double-Blind, Placebo-Controlled, Parallel Multicenter Phase Iii Study To Evaluate The Effectiveness And Safety Of Vhakm- Akkermansia Muciniphila Sleep, Stress And Cognition Study.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
BLEN-002-24, Version : 01, Date: 04 May 24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Radha Parthasarathy 
Designation  Principal Investigator 
Affiliation  Srinivasan Rajalakshmi Memorial Hospital (SRMH) 
Address  Room No.101,General Medicine Department,Srinivasan Rajalakshmi Memorial Hospital (SRMH) 7/1, Voltas Colony, Nanganalur, Chennai.

Chennai
TAMIL NADU
6000061
India 
Phone  9840117136  
Fax    
Email  radhaparthasarathy171@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Radha Parthasarathy 
Designation  Principal Investigator 
Affiliation  Srinivasan Rajalakshmi Memorial Hospital (SRMH) 
Address  Room No.101,General Medicine Department,Srinivasan Rajalakshmi Memorial Hospital (SRMH) 7/1, Voltas Colony, Nanganalur, Chennai.

Chennai
TAMIL NADU
6000061
India 
Phone  9840117136  
Fax    
Email  radhaparthasarathy171@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Radha Parthasarathy 
Designation  Principal Investigator 
Affiliation  Srinivasan Rajalakshmi Memorial Hospital (SRMH) 
Address  Room No.101,General Medicine Department,Srinivasan Rajalakshmi Memorial Hospital (SRMH) 7/1, Voltas Colony, Nanganalur, Chennai.

Chennai
TAMIL NADU
6000061
India 
Phone  9840117136  
Fax    
Email  radhaparthasarathy171@gmail.com  
 
Source of Monetary or Material Support  
Vidya Herbs Pvt Ltd, Vidya Building, N3-3, 24th Main Rd, 1st Phase, J. P. Nagar, Bengaluru, Karnataka 560078, India 
 
Primary Sponsor  
Name  Vidya Herbs Pvt LTD 
Address  Vidya Herbs Pvt LTD, Vidya Building N3-3, 24th Main, JP Nagar, 1st Phase, Bangalore-560078, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Radha Parthasarathy  Srinivasan Rajalakshmi Memorial Hospital (SRMH)  Room No.101, General Medicine Department, Srinivasan Rajalakshmi Memorial Hospital (SRMH) 7/1, Voltas Colony, Nanganalur, Chennai-600061, Tamil Nadu, India.
Chennai
TAMIL NADU 		 9840117136

radhaparthasarathy171@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Chennai Ethical Committee  Approved 
Panimalar Medical College Hospital & Research Institute- Institutional Human Ethics Committee  Approved 
Rajalakshmi Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Dose: Take one capsules or as directed, best taken prior to a meal. Frequency: One Capsule or as directed Route of Administration: Oral Total Duration of such Intervention:56 days  
Intervention  VHAKM- Akkermansia muciniphila  Dose: Take one capsules or as directed, best taken prior to a meal. Frequency: One Capsule or as directed. Route of Administration: Oral Total Duration of such Intervention:56 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age 18 Years to 65 Years
Both males and females
Patients willing to provide written informed consent and comply with protocol requirements. 
 
ExclusionCriteria 
Details  Any patient with weight or appetite loss, iron deficiency anemia, fever or rectal bleeding,
Known inflammatory bowel disease or celiac disease patients, Immunocompromised patients, Pregnancy or wishing to become pregnant during the study,
End-stage kidney failure on dialysis, presence of other diseases, including cancer or severe
hepatic insufficiency, The use of other probiotic products or antibiotics over the previous 6 months, Participation in other clinical trials 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Change in the reaction time (in milliseconds) will be measured at from using a
computerized task-switching color-word Stroop task following acute stress from baseline to Day 60, Self reported cognitive control and cognitive flexibility as per the Cognitive Control and
Flexibility Questionnaire (CCFQ) in a non-stressful condition, Anxiety subscale score of the Depression, Anxiety, and Stress Scale Short Form (DASS-21) total Pittsburgh Sleep Quality Index (PSQI) scores. 		 Visit 01(Day 01) Baseline Screening and Enrollment Visit, Visit 04 Day 45 (Interim visit), Visit 05 (Day 60 ± 3 days) Final Visit. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in the Accuracy (proportion correct; %false alarms) on a computerized taskswitching and an incongruent CWST, a go/no-go paradigm, a visual working memory maintenance paradigm, and a visual working memory complex span task (SYMSPAN)
from baseline to Day 60 (end of study), Change in Self-reported cognitive control and cognitive flexibility as per the Cognitive Control and Flexibility Questionnaire (CCFQ) in a non-stressful condition from baseline to Day 60 (end of study), Change in Anxiety subscale score of the Depression, Anxiety, and Stress Scale Short Form (DASS-21) total Pittsburgh Sleep Quality Index (PSQI) scores from baseline to Day 60
(end of study), Change in the Generalized Anxiety Disorder-7 (GAD-7) score from baseline to Day 60.
(end of study) 		 Visit 01(Day 01) Baseline Screening and Enrollment Visit, Visit 04 Day 45 (Interim visit), Visit 05 (Day 60 ± 3 days) Final Visit. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   26/09/2024 
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="2"
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  

Study Title- A Randomized double-blind, placebo-controlled, parallel multicenter phase III study to evaluate evaluate the effectiveness and safety of VHAKM-Akkermansia muciniphila sleep, stress and cognition study

Study Population- 60 Patients with Irritable Bowel Syndrome

Study Duration- 2 Months (60 days)

Study Design-  A randomized double-blind, placebo-controlled, parallel,multi-center, phase 3 clinical trial.

Inclusion Criteria-

Age 18 Years to 65 Years

Both males and females

Patients willing to provide written informed consent and comply with protocol requirements.

Exclusion Criteria –

Any patient with weight or appetite loss, iron deficiency anemia, fever or rectal bleeding,

Known inflammatory bowel disease or celiac disease patients, Immunocompromised patients, Pregnancy or wishing to become pregnant during the study,

End-stage kidney failure on dialysis, presence of other diseases, including cancer or severe

hepatic insufficiency, The use of other probiotic products or antibiotics over the previous 6 months, Participation in other clinical trials

Dose and Mode of Administration-

Take one capsule or as directed, best taken prior to a meal. Frequency: One Capsule or as directed Route of Administration: Oral

Primary Outcome Measure-

Change in the reaction time (in milliseconds) will be measured at from using a computerized task-switching color-word Stroop task following acute stress from baseline to Day 60, Self reported cognitive control and cognitive flexibility as per the Cognitive Control and Flexibility Questionnaire (CCFQ) in a non-stressful condition, Anxiety subscale score of the Depression, Anxiety, and Stress Scale Short Form (DASS-21) total Pittsburgh Sleep Quality Index (PSQI) scores.

Secondary Outcome Measures-

Change in the Accuracy on a computerized task switching and an incongruent CWST, a go/no-go paradigm, a visual working memory maintenance paradigm, and a visual working memory complex span task (SYMSPAN) from baseline to Day 60 (end of study),

Change in Self-reported cognitive control and cognitive flexibility as per the Cognitive Control and Flexibility Questionnaire (CCFQ) in a non-stressful condition from baseline to Day 60 (end of study),

Change in Anxiety subscale score of the Depression, Anxiety, and Stress Scale Short Form (DASS-21) total Pittsburgh Sleep Quality Index (PSQI) scores from baseline to Day 60 (end of study),

Change in the Generalized Anxiety Disorder-7 (GAD-7) score from baseline to Day 60.
(end of study)

Clinical evaluation-

·         Haematological and hepatic biomarkers were analyzed following the standard medical test protocols at screening (baseline) and end of treatment (Day 60)

·         Vital signs measurement and physical examination will be carried out at Screening, day 1, day 14, day 28, day 45 and day 60.

Evaluation Schedule-

Visit 01(Day 01) Baseline-

• Informed consent

• Demographic data

• Medical and surgical history

• Medication history

• Physical examination

• Vital signs

• Checking of eligibility criteria

• Randomization

• Dispensing of study medication

• Fasting Blood sugar level

• Subject treatment and diary filling instruction

• Providing patient diary

• Reaction time (milliseconds) using a computerized task-switching color-word Stroop task following acute stress.

• Accuracy on various cognitive tasks.

• Self-reported cognitive control and cognitive flexibility scores on the CCFQ in a non stressful condition.

• Anxiety subscale score of the DASS-21 total PSQI scores.

• Generalized Anxiety Disorder-7 (GAD-7) scores.

Visit 04 (Day 42) Interim visit.

• Fasting Blood sugar level

• Lipid profile

• Change in reaction time (milliseconds) using a computerized task-switching color-word

Stroop task following acute stress.

• Change in accuracy on various cognitive tasks.

• Change in self-reported cognitive control and cognitive flexibility scores on the CCFQ in a non-stressful condition.

• Anxiety subscale score of the DASS-21 total PSQI scores.

• Generalized Anxiety Disorder-7 (GAD-7) scores.

Visit 05 (Day 60 ± 3 days) End of Treatment Visit

• General physical examination

• Vital signs

• Physical examination

• Collection of patient diary and checking treatment compliance

• Vital signs

• Fasting Blood sugar level

• Change in reaction time (milliseconds) using a computerized task-switching color-word Stroop task following acute stress.

• Change in accuracy on various cognitive tasks.

• Change in self-reported cognitive control and cognitive flexibility scores on the CCFQ in a non-stressful condition.

• Change in anxiety subscale score of the DASS-21 total PSQI scores.

• Change in the Generalized Anxiety Disorder-7 (GAD-7) scores.

Safety Endpoints-

• Number of participants who experienced at least one Adverse Event during the study duration.

• Number of participants who discontinued study drug due to an Adverse Event during the study

Ethical Considerations-

The study will be conducted as per the National Ethical Guidelines for Biomedical and Health Research involving Human participants ICMR (2017), ICH (Step 5) ’Guidance on Good Clinical Practice’, New Drugs and Clinical Trials Rules 2019 G.S.R. 227(E) dated 19 Mar 2019, ’Good Laboratory Practice’, ‘Good Clinical Practices for Clinical Research in India’ Guidelines, Good Clinical Laboratory Practice (GCLP) and Declaration of Helsinki (Fortaleza, October 2013).

 

 

 

 
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