| CTRI Number |
CTRI/2013/04/003537 [Registered on: 09/04/2013] Trial Registered Retrospectively |
| Last Modified On: |
14/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Evaluation of effect of Withania somnifera (Ashwagandha) on mental performance tests |
|
Scientific Title of Study
|
Effect of standardized aqueous extract of Withania somnifera on tests of cognitive and psychomotor performance in healthy human participants. |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CPT_ICMR_10, Version-1, Version date August 25 2010 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Usharani |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Clinical Pharmacology and Therapeutics
Nizams Institute of Medical Sciences
Panjagutta
Hyderabad
Department of Clinical Pharmacology and Therapeutics
Nizams institute of Medical Sciences
Panjagutta
Hyderabad
Hyderabad
ANDHRA PRADESH
500082
India |
| Phone |
9849574143 |
| Fax |
|
| Email |
ushapingali@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Usharani |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Clinical Pharmacology and Therapeutics
Nizams Institute of Medical Sciences
Panjagutta
Hyderabad
Department of Clinical Pharmacology and Therapeutics
Nizams institute of Medical Sciences
Panjagutta
Hyderabad
Hyderabad
ANDHRA PRADESH
500082
India |
| Phone |
9849574143 |
| Fax |
|
| Email |
ushapingali@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Usharani |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Clinical Pharmacology and Therapeutics
Nizams Institute of Medical Sciences
Panjagutta
Hyderabad
Department of Clinical Pharmacology and Therapeutics
Nizams institute of Medical Sciences
Panjagutta
Hyderabad
Hyderabad
ANDHRA PRADESH
500082
India |
| Phone |
9849574143 |
| Fax |
|
| Email |
ushapingali@yahoo.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
P.O. Box No. 4911
Ansari Nagar
New Delhi - 110029
India
|
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Usha Rani |
Department of Clinical Pharmacology & Therapeutics |
Nizams Institute of Medical Sciences
Panjagutta
Hyderabad
ANDHRA PRADESH |
9849574143
ushapingali@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Nizams Institute of Medical Sciences |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
cognitive and psychomotor performance |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Capsule |
Dose : 250 mg Capsule
Route of Administration:Oral
Treatment Duration : 14 days
Subjects were asked to take 2 capsules BD with 240 ml of water daily for 14 days.
|
| Intervention |
Withania somnifera Capsules, |
Dose : 250 mg Capsule
Route of Administration:Oral
Treatment Duration : 14 days
Subjects were asked to take 2 capsules BD with 240 ml of water daily for 14 days.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Participants willing to sign informed consent
2. Participants with normal healthy conditions- Normal vitals, Physical examination, Normal weight and height as per LIC chart
No H/o of neuropsychological and psychiatric disorders.
Participants with normal to corrected vision.
Able to perform the test procedures, as per the protocol.
|
|
| ExclusionCriteria |
| Details |
1.H/o of psychiatric illiness, insomnia, use of any psychiatric medication.
2.H/o of drug dependence or any severe co-morbid medical conditions.
3.H/o of serious adverse reactions or hypersensitivity to any drug.
4.Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study.
5. Abnormality in routine lab investigations like complete blood picture, complete urine examination, liver function tests or renal function tests.
6.Participating in any drug trials/ research projects over the past 3 months.
7.Alcohol consumption 24 hrs before study day.
8.Tea/Coffee consumption or smoking 12 hrs before the study day.
9.Pregnant/breast feeding/ child bearing potential participants.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Mean percentage change in reaction time in cognitive and psychomotor tests on treatment with withania somnifera extract compared to placebo |
Baseline (Day-1) and Post Treatment(Day 15) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and tolerability of withania somnifera extract capsules |
Baseline (Day-1) and Post Treatment(Day 15) |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/09/2011 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
Background : Withania somnifera is an herbal medicine that has traditionally been attributed to memory-enhancing properties.
The current study involved an assessment of cognitive and psychomotor effects of standardized aqueous extract of Withania somnifera in healthy human participants.
Materials and Methods : In a randomized, placebo-controlled, double-blind, crossover, prospective study, 20 healthy participants received 500 mg twice daily of encapsulated dried root and leaf aqueous extract of Withania somnifera or a matching placebo for 14 days with a wash out period of 10-14-days. Cognitive and psychomotor performance was assessed predose (day1) and at 3 hrs postdose on day 15 using the battery of computerized psychometric tests.
Results : Significant improvements were observed in reaction times with simple reaction, choice discrimination, digit symbol substitution, digit vigilance and card sorting tests with Withania somnifera extract compared to placebo . However no effect can be seen with the finger tapping test.
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