| CTRI Number |
CTRI/2018/05/013797 [Registered on: 09/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
25/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Pharmaceutico-Analytical Study of Rajat Bhasma, Shankhpushpi syrup and clinical evaluation of Rajat Bhasma with Shankhpushpi syrup as Memory Enhancer i.e. Medhya. |
|
Scientific Title of Study
|
A Pharmaceutico-Analytical Study of Rajat Bhasma, Shankhpushpi Syrup and Clinical evaluation of Rajat Bhasma with Shankhpushpi Syrup as Medhya. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pritika Devi |
| Designation |
P G Scholar |
| Affiliation |
R G G PG Ayurvedic College and Hospital Paprola H P |
| Address |
Dept Ras Shastra and Bhaishajya Kalpana R G Govt PG Ayurvedic College and Hospital Paprola
Dept Ras Shastra and Bhaishajya Kalpana R G Govt PG Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9736651011 |
| Fax |
09736651011 |
| Email |
prritikka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C P Kashyap |
| Designation |
H O D |
| Affiliation |
R G G PG Ayurvedic College and Hospital Paprola H P |
| Address |
Dept Ras Shastra and Bhaishajya Kalpana R G G PG Ayurvedic College and Hospital Paprola
Dept Ras Shastra and Bhaishajya Kalpana R G Govt PG Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418496772 |
| Fax |
09736651011 |
| Email |
chanderpaul.kashyap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pritika Devi |
| Designation |
PG Scholar |
| Affiliation |
R G G PG Ayurvedic College and Hospital Paprola H P |
| Address |
Dept Ras Shastra and Bhaishajya Kalpana R G Govt PG Ayurvedic College and Hospital Paprola
Dept Ras Shastra and Bhaishajya Kalpana R G Govt PG Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9736651011 |
| Fax |
|
| Email |
prritikka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Govt. PG Ayurvedic College Paprola HP |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt PG Ayurvedic College Paprola HPR |
| Address |
Rajiv Gandhi Govt PG Ayurvedic College and Hospital Paprola Dist Kangra Himachal Pradesh |
| Type of Sponsor |
Government medical college |
|
|
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 C P Kashyap |
RGGPGAy College and Hospital, Paprola |
Ras shastra & bhaishajya kalpana department Pharmacy Building
Kangra
HIMACHAL PRADESH |
9418496772
chanderpaul.kashyap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients with memory problems |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Rajat Bhasma, Shankhpushpi Syrup |
Rajat Bhasma 100mg OD Shankhpushpi Syrup 10ml BD with Luke Warm Water |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients willling for clinical trial and ready to give written consent irrespective of sex uncomplicated cases of memory problems |
|
| ExclusionCriteria |
| Details |
Patients not willling for the trial
Patients not fulfilling the inclusion criteria
Patients below the age group of 15year and above 60 year
Complicated case of Memory related Problems |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Awaited |
Awaited |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Awaited |
May 2018 |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/02/2018 |
| Date of Study Completion (India) |
16/04/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Nowadays, anxiety, depression and other psychological
disorders ,is the major problem due to
undisciplined and hectic lifestyle. Day
to day stress of work, family issues, sleeping distrubances, late night work,
excessive use of phone, laptop also adds
negative impact on mental health.
This trend is fastly affecting all the population and
problem is likely to increase in future. Ayurveda considers Pragyapradh as the root cause of all
diseases (ch.sha.1/102). Medha and budhi are the synonyms of pragya as per
ayurvedic texts. Therefore it can be correlated with Medha that has a great role in prevention of diseases and
maintainace of good health. Many references of various Medhya herbal drugs and Bhasma
in classical texts confirm the importance of Medha, which incorpartes Dhee, Dhriti,and
Smriti.
Keeping this view in
mind , Rajat Bhasma and Shankhpushpi Syrup has been selected for the present
study. Thus the present study “ A
Pharmaceutico-Analytical Study of Rajat Bhasma, Shankhpushpi Syrup and its clinical
evaluation of Rajat Bhasma with Shankhpushpi syrup as Medhya ’’
|