| CTRI Number |
CTRI/2014/12/005312 [Registered on: 18/12/2014] Trial Registered Retrospectively |
| Last Modified On: |
21/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Prevention and management of neurodegenerative disorders by an Ayurvedic formulation |
|
Scientific Title of Study
|
Clinical Trial on role of an Ayurvedic formulation in the prevention and management of Neurodegenerative disorders |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| K.11022/10/2009-DCC (AYUSH) |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Govind Prasad Dubey |
| Designation |
Distinguished Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450963942 |
| Fax |
05422369937 |
| Email |
gpdubey13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Govind Prasad Dubey |
| Designation |
Distinguished Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450963942 |
| Fax |
05422369937 |
| Email |
gpdubey13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aruna Agrawal |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Dept. of Kriya Sharir, Faculty of Ayurveda
Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415263364 |
| Fax |
|
| Email |
aruna.agrawal12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University |
| Tulsi Ayurvedic Products & Research Pvt. Ltd. Bhadohi |
|
|
Primary Sponsor
|
| Name |
Department of Science Technology |
| Address |
Dept. of Science & Technology
Govt. of India
Technology Bhawan, New Mehrauli Road
New Delhi-110016 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Aruna Agrawal |
Professor, Dept. of Kriya Sharir, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi- 221 005 |
| Prof RG Singh |
Professor, Dept. of Nephrology, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221 005 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof R G Singh |
Institute of Medical Sciences, Banaras Hindu University |
Institute of Medical Sciences, Banaras Hindu University,-221005
Varanasi
UTTAR PRADESH |
9839080939
05422369937
directorims@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Adesh Institute of Medical Sciences & Research |
Approved |
| Institute of Medical Sciences, Banaras Hindu University, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, Neurodegenerative disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional drug treatment Donepzil 10mg twice per day for a period of 1 year |
10mg 8 AM and 10mg 8 PM. The followup studies were conducted as per standard qualifying norms and effect of conventional drug was assess on anti-oxidant, anti inflammatory as well as neuropsychological parameters |
| Intervention |
Test formulation 500mg twice per day for a period of 1 year |
The shade dried whole plant of Bacopa monnieri, fruits of Hippophae rhamnoides and rhizome of Dioscorea bulbifera was utilized to obtain hydro-alcoholic extract for preparation of combined formulation. The effective dose of each plant extract was determined in pre-clinical studies. The extract contained the quantified active constituents along with other compositions. The safety and efficacy was evaluated by conducting various experimental and clinical studies. The beneficial role of test formulation was determined on various biological markers involved with neurodegenerative disorders. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Willingness to give informed consent and a deterioration of memory along with at least three of the following five complaints:
1. Poor orientation
2. Poor judgement and problem solving difficulties
3. Trouble in the functioning of community affairs
4. Inability to function independently in home and during hobbies
5. Difficulties in personal care.
Clinical screening for SDAT was done using dementia rating scale-II
|
|
| ExclusionCriteria |
| Details |
Subjects suffering from any metabolic disease
Established neuropathy or tuberculosis
SDAT patients receiving conventional treatment were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in cognitive function particularly memory performance including behavioral abnormalities |
Gradual improvement (3,6,9 and 12 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect on oxidative stress markers, anti-inflammatory activity, homocysteine lowering effects, improvement in attention span, new learning, orientation skill and improvement in sleep pattern |
Gradual improvement (3,6,9 and 12 months) |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2007 |
| 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 |
|
Estimated Duration of Trial
|
Years="6"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Sadhu A, Upadhyay P, Agrawal A, Ilango K, Karmakar D, Singh GP, Dubey GP. Management of cognitive determinants in senile dementia of Alzheimers type: therapeutic potential of a novel polyherbal drug product. Clin Drug Investig. 2014 Dec;34(12):857-69.
Prabhat Upadhyay, Ananya Sadhu, Praveen K. Singh, Aruna Agrawal, K. Ilango, Suresh Purohit, Govind Prasad Dubey. Revalidation of the neuroprotective effects of a United States patented polyherbal formulation on scopolamine induced learning and memory impairment in rats,
Biomedicine & Pharmacotherapy, Volume 97,2018, Pages 1046-1052,ISSN 0753-3322.
Rastogi M, Ojha RP, Prabu PC, Devi BP, Agrawal A, Dubey GP. Prevention of age-associated neurodegeneration and promotion of healthy brain ageing in female Wistar rats by long term use of bacosides. Biogerontology. 2012 Apr;13(2):183-95. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A randomized double-blind placebo and active controlled clinical trial will be performed in healthy elderly subjects and SDAT patients with age more than 60 years. The polyherbal test formulation along with a placebo will be given to healthy elderly subjects while the SDAT patients will receive either the test formulation containing extracts of Bacopa monnieri (whole plant), Hippophae rhamnoides (fruits) and Dioscorea bulbifera (bulbils) at a dose of 500mg or donepezil drug (comparator agent) at a dose of 10mg twice daily, for a period of 12 months. After every three months, cognitive function will be assessed as primary outcome measures by determining the MMSE score, DSS Score, Immediate and Delayed word recall, attention span, functional activity questionnaire and depression score. Further inflammatory markers and level of oxidative stress markers will be analyzed using standard biochemical tests |