| CTRI Number |
CTRI/2017/02/007764 [Registered on: 02/02/2017] Trial Registered Prospectively |
| Last Modified On: |
03/07/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
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Type of Study
|
Drug |
| Study Design |
Single Arm Study |
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Public Title of Study
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An Open Label, Multicentre, Phase IV Study to Evaluate the Safety and Treatment Effects of Tebokan® forte (Ginkgo Biloba EGb 761®) One Tablet of 120 mg Twice Daily in Adult Patients with Dementia |
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Scientific Title of Study
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An Open Label, Multicentre, Phase IV Study to Evaluate the Safety and Treatment Effects of Tebokan® forte (Ginkgo Biloba EGb 761®) One Tablet of 120 mg Twice Daily in Adult Patients with Dementia |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr R Valavan |
| Designation |
Head Scientific Affairs |
| Affiliation |
Dr. Willmar Schwabe India Pvt Ltd |
| Address |
A-36, Sector - 60, Phase-III, Noida
A-36, Sector - 60, Phase-III, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201304
India |
| Phone |
01204016500 |
| Fax |
01204016583 |
| Email |
Dr.valavan@schwabeindia.com |
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Details of Contact Person
Public Query
|
| Name |
Ravi Kumar Manchanda |
| Designation |
Manager Regulatory Affairs |
| Affiliation |
Dr. Willmar Schwabe India Pvt Ltd |
| Address |
A-36, Sector - 60, Phase-III, Noida
A-36, Sector - 60, Phase-III, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201304
India |
| Phone |
01204016500 |
| Fax |
01204016583 |
| Email |
ravi.manchanda@schwabeindia.com |
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Source of Monetary or Material Support
|
| Dr Willmar Schwabe India Pvt Ltd
A 36 Phase 3 Sector 60 Noida 201304
District Gautam Budh Nagar Uttar Pradesh India |
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Primary Sponsor
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| Name |
Dr Willmar Schwabe India Pvt Ltd |
| Address |
A-36 Phase III Sector 60
Noida
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| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
Sites of Study
Modification(s)
|
| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yogesh Kumar Gupta |
Ganadhipati Purushottam Shekhawati Hospital & Research Centre |
A/2, opposite (Time Square), Central Spine, Vidhyadhar Nagar,Jaipur 302023, Rajasthan, India
Jaipur
RAJASTHAN |
01412232211
01412232194
info@shekhawatihospital.org |
| Dr PN Renjan |
Indraprastha Apollo Hospitals |
Department of Neurology
Indraprastha Apollo Hospitals
Sarita Vihar
Delhi Mathura Road
New Delhi
DELHI |
011-41677024
pnrenjan@rediffmail.com |
| Dr Pradip Kumar Saha |
Institue of Postgraduate Medical Education and Research |
Institute of Post Graduate Medical Education and Research
244, AJC Bose Road
Kolkata 700020, West Bengal
Kolkata
WEST BENGAL |
8116439237
info@gmail.com |
| Dr Jaykumar Gunjkar |
Lifepoint Multispecialty Hospital, Pune |
Lifepoint Multispecialty Hospital, 145/1, Mumbai – Bangalore Highway, Near Wakad, Pune - 411057
Pune
MAHARASHTRA |
02066434343
02043434399
gunjkar.jaykumar118@gmail.com |
| Dr Ajit Kumar Roy |
Manipal Hospital |
Department of Neurology, #98, HAL Airport Road, Bangalore-560 017, Karnataka, India.
Bangalore
KARNATAKA |
080-25024631
ajith.kumar@manipalhospitals.com |
| Dr Puneet Agarwal |
Max Super Specialty Hospital |
Max Super Specialty Hospital West Block
1 Press Enclave Road
Saket New Delhi
New Delhi
DELHI |
011-66115050
puneet.agarwal@maxhealthcare.com |
| Dr Vemireddy Radhika Reddy |
Old Govt. General Hospital (associated by Govt. Siddhartha Medical College) |
Department Of Psychiatry, Hanumanpet, Two Town, Vijayawada - 520001, Andhra Pradesh, India
Krishna
ANDHRA PRADESH |
08662450391
rrvemireddy@yahoo.com |
| Dr Debashish Chowdhury |
Postgraduate Medical Education & Research (GIPMER |
Department of Neurology
GB Pant Institute of Postgraduate Medical Education and Research
Jawaharlal Nehru Marg
New Delhi 110002
New Delhi
DELHI |
011-23234242
debashishchowdhury@hotmail.com |
| Dr S Vijaya Bhaskara Gupta |
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt General Hospital |
Rajiv Gandhi Institute of Medical Sciences (RIMS) Govt General Hospital Research Wing
2nd Floor Beside FM Ward
Srikakulam
Srikakulam
ANDHRA PRADESH |
9440069415
rimsrearch@gmail.com |
| Dr Vaishal Vora |
Ratandeep Multispecialty Hospital |
2nd Floor
Nakshatra Complex
Above HDFC Bank
Maninagar Crossroads
Maninagar
Ahmadabad
GUJARAT |
079-22124022
vnvora@gmail.com |
| Dr Subarna Telang |
Ruby Hall Clinic Grant Medical Foundation |
Clinical Research Department
Cancer Building
1st Floor Room No 107
Ruby Hall Clinic 40 Sassoon Road Pune 411001 Maharashtra
Pune
MAHARASHTRA |
020-66455628
suparnashri@yahoo.com |
| Dr Sangeetha Ravat |
Seth GS Medical College KEM Hospital |
Ward No 10
2nd Floor
Old Building
Department of Neurology
Seth GSMC & KEM Hospital
Parel
Mumbai 400012
Mumbai
MAHARASHTRA |
022-24164206
ravatsh@yahoo.com |
| Dr Anoop Vincent |
Sree Narayana Institute of Medical Sciences |
2nd Floor Dept Of Psychiatry
Challaka N-Kuthiya Thodu Ernakulam
Ernakulam
KERALA |
0484-2478093
anoop.vincent@yahoo.co.in |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospital, Bangalore |
Approved |
| Ethics Committee of Siddhartha Medical College and Govt Hospital Vijayawada |
Approved |
| Ganadhipati Purushottam Shekhawati Hospital & Research Centre Ethics Committee |
Approved |
| Institutional Ethics Committee - Maulana Azad Medical College, 3rd Floor, Room No 306A, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi |
Approved |
| Institutional Ethics Committee Institute of Postgraduate Medical Education and Research |
Approved |
| Institutional Ethics Committee Rajiv Gandhi Institute of Medical Science and RIMS Government General Hospital |
Approved |
| Institutional Ethics Committee, Seth GS Medical College KEM Hospital, Parel, Mumbai |
Approved |
| Institutional IndraprasthaApolloHospitalsSaritaViharDelhiMathuraRoadNewDelhi |
Approved |
| LPR Ethics Committee, Lifepoint Multispecialty Hospital |
Approved |
| Max Healthcare Ethics Committee, Max Super Specialty Hospital , 1 Press Enclave Road, Saket, New Delhi |
Not Applicable |
| RatandeepMultispecialtyHospital |
Approved |
| RubyHallClinicGrantMedicalFoundation |
Approved |
| SreeNarayanaInstituteofMedicalSciencesChallaka |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Patients diagnosed with dementia including Alzheimers disease vascular dementia or mixed dementia, |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Tebokan® forte (Ginkgo biloba leaves extract (EGb 761®) |
Dose 120 mg film coated tab
Frequency Twice Daily
Route of Administration Oral
Total duration of therapy
18 weeks |
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Inclusion Criteria
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| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects with at least 50 years of age
2 Subjects diagnosed with dementia specifically Major Neurocognitive Disorder due to Alzheimers disease Major Vascular Neurocognitive Disorder or mixed form of both in accordance with DSM 5 criteria cf section 4 1 1
3 MMSE between 12 and 24 inclusive 12 to 18 moderate dementia and 19 to 24 mild dementia
4 Presence of a caregiver
5 Subject LAR ready to give written consent to participate in the trial and ready to follow all study related procedures
6 Post menopausal female subjects or non menopausal female subjects with negative serum pregnancy test and willing to use a reliable means of contraception other than or in addition to hormonal contraceptives eg double barrier method diaphragm plus spermicide condom plus spermicide, etc surgical sterilization or abstinence for the duration of the study.
7 Subjects not participating in any other clinical trial since last 6 months
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| ExclusionCriteria |
| Details |
Subjects diagnosed with dementia except AD VD or mixed dementia
Subjects currently undergoing treatment for depression
Subjects with major depression or other psychiatric disorder hospitalized for depression within one year prior to baseline visit
Use of Ginkgo biloba within 8 weeks prior to baseline visit
Use of cholinesterase inhibitor within 6 months of baseline visit
History of any bleeding abnormalities other than in the context of anti platelet or anti coagulant drugs
Any other type of neurological disorder as per investigator s discretion
Active malignant disease HIV or serious infection as per investigators discretion
Subjects currently on cognitive enhancers cholinergic anti cholinergic or haemorheologically active drugs
Severe or insufficiently controlled cardiovascular renal or hepatic disorder diabetes anaemia or thyroid dysfunction as per investigator s discretion
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
Number of presumed adverse drug reactions and percentage of subjects with presumed adverse drug reactions between baseline and week 18
Number of adverse events and percentage of subjects with adverse events between baseline and week 18
Number of serious adverse events and percentage of subjects with serious adverse events between baseline and week 18
Changes in the vital signs physical and laboratory examination between baseline and week 18 |
baseline and week 18 |
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Secondary Outcome
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| Outcome |
TimePoints |
| Change from baseline to week 18 in a picture learning test representing attention and memory CERAD constructional praxis and recall of constructional praxis |
baseline and week 18 |
| Change from baseline to week 18 in the Trail Making Test A and B representing speed and executive functioning |
baseline and week 18 |
| Number and percentage of patients with improvement in cognitive functioning from baseline to week 18 for Trail Making Test and CERAD constructional praxis and recall of constructional praxis either or both |
baseline and week 18 |
| Change from baseline to week 18 in the BEHAVE AD |
baseline and week 18 |
| Change in CGI scale from baseline to week 18 |
baseline and week 18 |
| Number and percentage of subjects improving or recovering from vertigo and or tinnitus from baseline through week 18 via 11 Point Box Scales for vertigo and tinnitus |
baseline and week 18 |
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Target Sample Size
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Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 4 |
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Date of First Enrollment (India)
|
20/03/2017 |
| 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 |
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Estimated Duration of Trial
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Years="1"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This is an open label, multicentre, phase IV study to assess the safety and therapeutic effects of Tebokan® forte (Ginkgo biloba dry extract EGb 761®) one tablet of 120 mg administered twice daily in subjects diagnosed with dementia. In this study subjects with at least 50 years of age and diagnosed with dementia in accordance with DSM-5 criteria will be enrolled. During the study a care giver should always accompany with the subject. |