| CTRI Number |
CTRI/2019/12/022259 [Registered on: 05/12/2019] Trial Registered Prospectively |
| Last Modified On: |
30/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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A clinical trial to study the effect of kushmanand beej churn and satvavajaya chikitsa in the patient having sign and symptoms of dhee dhriti and smriti ( manas rog)
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Scientific Title of Study
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“An Etiopathological Study of impairment of Dhee Dhriti Smriti w.s.r. to Mild Cognitive Impairment and Therapeutic Evaluation of Kushmanda Beeja Churna and Satvavajaya Chikitsaâ€
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshu Sharma |
| Designation |
M.D. scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Roga Evam Vikriti Vigyan,National Institute of Ayurveda, jorawar singh gate madhav vilas palace , jaipur
P.G. Department of Roga Evam Vikriti Vigyan,National Institute of Ayurveda, jorawar singh gate madhav vilas palace ,jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8890233668 |
| Fax |
|
| Email |
anshusharma6668@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
professor surendra kumar sharma |
| Designation |
professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Roga Evam Vikriti Vigyan,National Institute of Ayurveda, jorawar singh gate madhav vilas palace , jaipur
P.G. Department of Roga Evam Vikriti Vigyan,National Institute of Ayurveda, jorawar singh gate madhav vilas palace , jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414361874 |
| Fax |
|
| Email |
drsksm31@rediffmail.com |
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Details of Contact Person
Public Query
|
| Name |
Anshu Sharma |
| Designation |
M.D. scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Roga Evam Vikriti Vigyan,,National Institute of Ayurveda, jorawar singh gate madhav vilas palace , jaipu
P.G. Department of Roga Evam Vikriti Vigyan,,National Institute of Ayurveda, jorawar singh gate madhav vilas palace , jaipu
Jaipur
RAJASTHAN
302002
India |
| Phone |
08890233668 |
| Fax |
|
| Email |
anshusharma6668@gmail.com |
|
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Source of Monetary or Material Support
|
| national institute of ayurveda jaipur |
|
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Primary Sponsor
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| Name |
NATIOINAL INSTITUTE OF AYURVEDA JAIPUR |
| Address |
NATIOINAL INSTITUTE OF AYURVEDA JORAWAR SINGH GATE AMER ROAD JAIPUR 302002 rajasthan |
| Type of Sponsor |
Research institution |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ANSHU SHARMA |
NATIOINAL INSTITUTE OF AYURVEDA HOSPITAL JAIPUR |
NATIONAL INSTITUTE OF AYURVEDA HOSPITAL AMER ROAD JAIPUR
Jaipur
RAJASTHAN |
8890233668
anshusharma6668@gmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics committee national institute of ayurveda |
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 |
(1) ICD-10 Condition: F19||Other psychoactive substance related disorders, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
kushmand beej churn |
6 gm BD with honey after meal |
| Comparator Agent |
kushmand beej churn and satvavajaya chikitsa |
6 gm BD as well as with honey and satvavajaya chikitsa |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The Individuals having the all age group more than 18 years with impairment of Dhee, Dhriti and Smriti. |
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| ExclusionCriteria |
| Details |
Schizophrenia, Parkinsonism, Dementia, Alzheimer, Uremia, Encephalopathy preganant women, lactating mother and any major systemic disorder. |
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| patients of both sexes age group above 18 years of dhee dhriti smriti will be selected for reliving sign and symptoms |
patients of both sexes age group above 18 years of dhee dhriti smriti will be selected for reliving sign and symptoms |
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Secondary Outcome
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| Outcome |
TimePoints |
| asses the comparative efficacy between both groups after 8 weeks in case of dhee dhriti and smriti impairment. |
asses the comparative efficacy between both groups after 8 weeks in case of dhee dhriti and smriti impairment |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
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Date of First Enrollment (India)
|
05/12/2019 |
| 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
|
Years="0"
Months="2"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Not Published Yet |
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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
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This is open label randomised single centre comparing efficacy of ayurvedic drug kushmand beej and kushmand beej ,satvavajaya chikitsa in the management of dhee, dhriti, smriti (mild coginitive impairment). Patients of both sexes age of 18 years and above of dhee dhriti smriti will be selected for relieving sign and symptoms. 60 clinically diagnoded and confirmed patients will be divided into two groups for administration of trial drug. In group A 30 patients will be administered trial drug kushmand beej in the dose of 6 gm BD orally for 60 days . In group B 30 patients will be administered trial drug kushmand beej as well as witrh satvavajaya chikitsa for 60 days . All the patients registered for clinical trial will be asked for any changes in their clinical manifestation and growing feeling of well being. conclusion - To compare the efficacy of both the groups. |