| CTRI Number |
CTRI/2022/03/040724 [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 POWDER as Nutritional Supplement. |
|
Scientific Title of Study
|
CLinical Study TO Evaluate the Efficacy and Safety of LION’S MANE POWDER (HERICIUM ERINACEUS) as 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 Sakthi Balan MD |
| Designation |
Principal Investigator |
| Affiliation |
Ki3, CRO |
| Address |
Thirumalai Clinic and Raghavendra Diagnostic Centre No153 Cuddalore main road Pondicherry
605004
India
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9843591097 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakthi Balan MD |
| Designation |
Principal Investigator |
| Affiliation |
Ki3, CRO |
| Address |
Thirumalai Clinic and Raghavendra Diagnostic Centre No153 Cuddalore main road Pondicherry
605004
India
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9843591097 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakthi Balan MD |
| Designation |
Principal Investigator |
| Affiliation |
Ki3, CRO |
| Address |
Thirumalai Clinic and Raghavendra Diagnostic Centre No153 Cuddalore main road Pondicherry
605004
India
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9843591097 |
| Fax |
|
| Email |
saheerose@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
|
|
|
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 |
Room No.2, No.38, Thesai Street, Walajabad, Vellore, Tamilnadu - 632513.
Vellore
TAMIL NADU
Vellore
TAMIL NADU |
9677786447
srkguruvarshan@gmail.com |
| Dr Sakthi Balan MD |
Thirumalai Clinic and Raghavendra Diagnostic Centre |
Room no. 1, No153 Cuddalore main road Pondicherry 605004 India
Pondicherry
PONDICHERRY |
9843591097
saheerose@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E648||Sequelae of other nutritional deficiencies. Ayurveda Condition: Apatarpanajanya vyadhis, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Lions Mane Mushroom, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 4 Weeks, Reference: NA, Route: NA, Dosage Form: Churna/ Powder, 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, 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) |
10/04/2022 |
| 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
|
Totally
24 subjects who fulfilled the inclusion and exclusion criteria will be enrolled
in the study. The selected subjects will receive 5g of Lion’s Mane Powder (Hericium Erinaceus)of DXN Manufacturing India Pvt. Ltd. once daily orally
before food for 4 weeks. The primary and secondary outcome parameters will be
assessed on respective time points and results will be analyzed statistically. |