| CTRI Number |
CTRI/2020/02/023297 [Registered on: 13/02/2020] Trial Registered Prospectively |
| Last Modified On: |
23/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Herbal formulation clinical trial on Cognitive adult patient |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled clinical study to evaluate comparative clinical Efficacy and Safety of BHC9612CP on Cognitive Function in Adult Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BH/CG/19/01 Versio 1.0 dated 18th December 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPoorna prasad |
| Designation |
Principla investigator |
| Affiliation |
|
| Address |
Room no 2 1st Floor
Sri venkateshwara Hospitals
No 27 29th Main Road Rashtra Kuvempu Nagara
BTM 2nd stage BTM layout Bengalore 560076
Karntaka India
Bangalore
KARNATAKA
560076
India |
| Phone |
|
| Fax |
|
| Email |
drpoornasv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShubarani |
| Designation |
Clinical trial-Investigator |
| Affiliation |
Bangalore Clinical Services |
| Address |
Bangalore Clinical Services
No265 3rd Floor 6th Main 4th Cross BTM 2nd Stage Bangalore 560076 India
Bangalore
KARNATAKA
560076
India |
| Phone |
9449453674 |
| Fax |
|
| Email |
dr.shubharani111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShubarani |
| Designation |
Clinical trial-Investigator |
| Affiliation |
Bangalore Clinical Services |
| Address |
Bangalore Clinical Services
No265 3rd Floor 6th Main 4th Cross BTM 2nd Stage Bangalore 560076 India
Bangalore
KARNATAKA
560076
India |
| Phone |
9449453674 |
| Fax |
|
| Email |
dr.shubharani111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Botanic Healthcare Pvt. Ltd
Plot No. 35, Mani Mansion Floor-1 Street-1 Secunderbad, Tarnaka, Hyderabad, Telangana 500017 |
|
|
Primary Sponsor
|
| Name |
Botanic Healthcare Pvt Ltd |
| Address |
No. 35, Mani Mansion Floor-1 Street-1 Secunderbad, Tarnaka, Hyderabad, Telangana 500017 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPoorna prasad |
Sri venkateshwara Hospitals |
Room no 2 1st Floor No 27 29th Main Road Rashtra Kuvempu Nagara
BTM 2nd stage BTM layout Bengalore 560076
Karntaka India
Bangalore
KARNATAKA |
9481594148
shettyshospital@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri venkateshwara Hospitals Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q049||Congenital malformation of brain,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BHC9612CP Capsule Test product |
Capsule dosage form
Three times daily after meal |
| Comparator Agent |
Placebo |
Capsule dosage form Three times daily after meal |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Both male and female subjects aged between 40-75 years with a complaint of memory impairment for at least one year without any major cognitive deficit.
2.Subjects who are willing to sign ICF
|
|
| ExclusionCriteria |
| Details |
1.Subjects with Psychiatric disorders
2.Subjects with alcohol consumption
3.Subjects with any organ system infection in past 30 days
4.Subjects with severe cognitive problems like dementia, function disability, post
5.vascular cerebral symptoms or with any neurological problems
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy and safety of Ashwagandha in subjects with cognitive impairment |
Day 0 Day 28 and Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Adverse events (AEs), frequency and severity.
2.Number of subjects who discontinue study due to adverse events
3.Changes in vital parameters and laboratory investigations
|
Day 0 Day 28 and Day 56 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/02/2020 |
| 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="6"
Days="0" |
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)?
|
|
Brief Summary
|
Earlier clinical studies using Nutraceutical
ingredients of herbal origin have demonstrated significant improvement in
symptoms of Cognition Based on the existing information we
hypothesized that Ashwagandha supplemented for 56 days would provide a
remarkable improvement of cognition.
Cognition is defined as ‘the mental action or
process of acquiring knowledge and understanding through thought, experience,
and the senses. Cognition is the mental processes relating to the input and
storage of information and how that information is then used to guide your
behavior. It is in essence, the ability to perceive and react, process and
understand, store and retrieve information, make decisions and produce
appropriate responses. The modern word ‘cognition’ actually has its roots back
to Latin, the word ‘cognoscere’ which is to ‘get to know’. With that in mind,
cognitive functioning is therefore critical for day-to-day life, governing our
thoughts and actions. We need cognition to help us understand information about
the world around us and interact safely with our environment, as the sensory
information we receive is vast and complicated: cognition is needed to distill
all this information down to its essentials
|