| CTRI Number |
CTRI/2016/10/007354 [Registered on: 13/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
14/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of Ashwagandha (Withania somnifera) in mild memory impairment |
|
Scientific Title of Study
|
Efficacy And Safety Of KSM66 Ashwagandha (Withania somnifera) In Cognitive Function In Healthy Adults: A prospective, Randomized, Double blind, Placebo controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KSM/Cog/Ad/01/2013, version number 1, date 6th Aug 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dnyanraj Choudhary |
| Designation |
Principal Investigator |
| Affiliation |
Atur Sangtani |
| Address |
Atur Sangtani, Red Cross House,
11 M.G.Road,
Pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
9823217423 |
| Fax |
|
| Email |
dr.dnyanrajc@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dnyanraj Choudhary |
| Designation |
Principal Investigator |
| Affiliation |
Atur Sangtani |
| Address |
Atur Sangtani, Red Cross House,
11 M.G.Road,
Pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
9823217423 |
| Fax |
|
| Email |
dr.dnyanrajc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dnyanraj Choudhary |
| Designation |
Principal Investigator |
| Affiliation |
Atur Sangtani |
| Address |
Atur Sangtani, Red Cross House,
11 M.G.Road,
Pune 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
9823217423 |
| Fax |
|
| Email |
dr.dnyanrajc@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shri Kartikeya Pharma |
| Address |
5-9-225, Sanali Estate, Abids, Hyderabad - 500001 Ph: (0091) 40-23204385 / 86 / 87 |
| 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 |
| Dr Dnyanraj Choudhary |
Atur Sangtani |
Red cross house, consulting room No. 1, Atur sangatani,11 M.G.Road, Pune 411001.
Pune
MAHARASHTRA |
9823217423
dr.dnyanrajc@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Of Chaitanya Hospital & Nursing Home, Pune for Dr. Dnyanraj Choudhary |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mild Cognition Impairment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capsule containing KSM-66 (Withania somnifera) |
One capsule twice daily orally for 8 weeks |
| Comparator Agent |
Capsule containing Placebo |
Placebo capsule identical to KSM 66 (Withania somnifera) but without active ingredients. One capsule twice daily orally for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult male or female patients aged greater than 35 years of age
2.Patients with early dementia or mild cognitive impairment
3.Have a screening Mini-Mental State Examination (MMSE) score of greater than or equal to 19 (mild or no memory impairment)
4.Patients with subjective memory complaints
5.Have the ability to understand the requirements of the study
6.Participants agree to abide by the study restrictions and return for the required assessments
7.Participants willing to sign informed consent
|
|
| ExclusionCriteria |
| Details |
1 Have a screening Mini-Mental State Examination (MMSE) score of less than 19(moderate and severe memory impairment)
2.Psychiatric with known neuropsychiatric conditions like Schizophrenia, Parkinsonism, Huntington’s disease, Picks disease etc.
3.Patients taking psychotropic drugs including alcohol
4.Patients taking any other drugs or alternative medicines for enhancement of memory
5.Patients with known persistent endocrine disorders
6.Patients with uncontrolled hypertension
7.Patients with uncontrolled diabetes mellitus
8.H/o of drug dependence or any severe co-morbid medical conditions
9.Pregnant and lactating women
10.Subjects with known hypersensitivity to Ashwagandha
11.History of major surgery within the past 6 months
12.Participation in other clinical trials during previous 3 months
13.Any clinical condition, according to the investigator which does not allow safe fulfillment of the study protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement from baseline in the composite score of Wechsler Memory Scale III (WMS-III) after therapy |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement from baseline in the Index scores of immediate memory after therapy. |
8 weeks |
| Improvement from baseline in the Index scores of General memory after therapy. |
8 weeks |
| Improvement from baseline in the Index scores of working memory after therapy. |
8 weeks |
| Improvement from baseline in the scores of visual reproduction I and II total score, visual reproduction II Recognition Total Score, visual reproduction II Copy Total Score and visual reproduction II discrimination Total Score after therapy |
8 weeks |
| Improvement from baseline in the score of Shepard’s mental rotation task after therapy |
8 weeks |
| Improvement from baseline in the score of Eriksen Flanker task after therapy |
8 weeks |
| Improvement from baseline in the score of Wisconsin card sort test after therapy |
8 weeks |
| Improvement from baseline in the score of Trail making test part A after therapy |
8 weeks |
| Improvement from baseline in the score of Mackworth’s sustained attention test after therapy |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/11/2013 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is A prospective, randomized, double-blind, placebo-controlled study to compare the efficacy of Ashwagandha in improving Cognitive Function in healthy adults. A total of 50 healthy adults subjects will be recruited in this study. Adult male or female subjects > 35 years of age, with early dementia or mild cognitive impairment, having Mini-Mental State Examination (MMSE) score ≥19 at baseline and having subjective memory complaints will be enroll in study. Study duration will be 8 weeks for each subject with baseline, week 4 & week 8 visits. Subjects were asked to take 1 capsule two times daily (total2 capsules per day) with water daily for 8 weeks. At the end of study primary outcome will be assessed as improvement from baseline in the composite score of Wechsler Memory Scale III (WMS-III) and secondary as improvement from baseline in the Index scores of immediate memory, General memory and working memory. Improvement from baseline in the visual reproduction score, Shepard’s mental rotation task score, Eriksen Flanker task score, Wisconsin card sort test score, Trail making test part A score and Mackworth’s sustained attention test score. Global assessment of tolerability will be performed by physician at the end of study. |