FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/03/040733 [Registered on: 02/03/2022] Trial Registered Prospectively
Last Modified On: 14/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To Find the Effect of LION’S MANE TABLET as a Nutritional Supplement 
Scientific Title of Study   Clinical Study to Evaluate the Efficacy and Safety of LION’S MANE TABLET (HERICIUM ERINACEUS) as a Nutritional Supplement in Patients with Co morbidities.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vivek MBBS MS 
Designation  Principal Investigator 
Affiliation  Ki3, CRO 
Address  Smiriti’s clinic, 17, pallavapuram, new colony, chromepet, Chennai

Kancheepuram
TAMIL NADU
600044
India 
Phone  9176054266  
Fax    
Email  drvivekcro@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek MBBS MS 
Designation  Principal Investigator 
Affiliation  Ki3, CRO 
Address  Smiriti’s clinic, 17, pallavapuram, new colony, chromepet, Chennai

Kancheepuram
TAMIL NADU
600044
India 
Phone  9176054266  
Fax    
Email  drvivekcro@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vivek MBBS MS 
Designation  Principal Investigator 
Affiliation  Ki3, CRO 
Address  Smiriti’s clinic, 17, pallavapuram, new colony, chromepet, Chennai

Kancheepuram
TAMIL NADU
600044
India 
Phone  9176054266  
Fax    
Email  drvivekcro@gmail.com  
 
Source of Monetary or Material Support  
DXN Manufacturing India Pvt Ltd R.S.NO.141/4 &142/5,WHRILPOOLROAD,THIRUVANDAR KOIL MANNADIPET COMMUNE,PONDY-102. PONDICHERRY-605102.  
 
Primary Sponsor  
Name  DXN Manufacturing India Pvt Ltd 
Address  R.S.NO.141/4 &142/5,WHRILPOOLROAD,THIRUVANDAR KOIL MANNADIPET COMMUNE,PONDY-102. PONDICHERRY-605102.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramesh Kannan  PM Medical Centre Vellore  No.38, Thesai Street, Walajabad, Vellore, Tamilnadu - 632513. Vellore TAMIL NADU
Vellore
TAMIL NADU 		 9677786447

srkguruvarshan@gmail.com 
Dr Vivek MBBS MS  Smiriti’s Clinic  17, pallavapuram, new colony, chromepet, Chennai-600044
Kancheepuram
TAMIL NADU 		 9176054266

drvivekcro@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ki3 Ethics Committee for AYUSH  Approved 
PM Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E089||Diabetes mellitus due to underlying condition without complications. Ayurveda Condition: Systemic hypertension or Diabetes Mellitus or Hyperlipidemia.,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Lions mane Mushroom, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 300(mg), Frequency: tds, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 4 Weeks, Reference: NA, Route: NA, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Participants aged 18-60 years (both sex).
2.Participants who are determined to be at risk for malnutrition based on the Malnutrition Screening Tool for adults and presenting with any one of the co morbidities like Systemic hypertension or Diabetes Mellitus or Hyperlipidemia. 
 
ExclusionCriteria 
Details  1. Participants presenting with fever and acute infections, will be excluded. 2. History of heart, liver or kidney failure. 3. Allergy or intolerance to the individual constituents in test product. 4. Patients with history of thyroid abnormalities. 5. Patients with history of any malignancy. 6. History of any Neurodegenerative disease. 7. Organ transplantation 8. Allergy to fungi 9. Subjects who are pregnant and lactating mothers, or with any serious disease condition limiting full adhesion to the protocol. 10. Participation in an investigational drug trial in the 30 days prior to the screening visit. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Improvement in the nutritional status based on Malnutrition screening tool, Mini Nutritional assessment & DETERMINE Your nutritional health checklist. [Baseline, week 4]
2.Improvement in Cognitive function by using Montreal Cognitive Assessment [Baseline and week 4] 		 Day 0 and 28 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement in BMI and mid arm circumference and various hematological and biochemical blood parameter will be monitored
2.Adverse event monitoring 		 Day 0 and 28 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   03/03/2022 
Date of Study Completion (India) 12/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="28" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. The selected subjects will receive Lions’s Mane Tablet (Hericium Erinaceus) two tablets each three times after breakfast, lunch and dinner daily for 4 weeks. The Patients will be on standard treatment for other co morbid conditions as per standard guidelines. 
Close