| CTRI Number |
CTRI/2022/03/040964 [Registered on: 10/03/2022] Trial Registered Prospectively |
| Last Modified On: |
04/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate the Efficacy and safety of nutraceutical formulation in neurodegenerative diseases linked to cognitive impairment |
|
Scientific Title of Study
|
A Clinical study to evaluate the efficacy and safety of nutraceutical formulation in neurodegenerative diseases linked to cognitive impairment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjana Mishra |
| Designation |
H.O.D Reader P.G dept. Of Kayachikitsa |
| Affiliation |
R.G.G.P.G ayu. College and hospital |
| Address |
H.O.D reader P.G. dept. Of kayachikitsa R.G.G.P.G ayu. College and hospital paprola kangra H.P.
V.P.O. Kharanal Distt. Kangra Himacahal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418312324 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjana Mishra |
| Designation |
H.O.D Reader P.G dept. Of Kayachikitsa |
| Affiliation |
R.G.G.P.G ayu. College and hospital |
| Address |
H.O.D reader P.G. dept. Of kayachikitsa R.G.G.P.G ayu. College and hospital paprola kangra H.P.
V.P.O. Kharanal Distt. Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418312324 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjana Mishra |
| Designation |
H.O.D Reader P.G dept. Of Kayachikitsa |
| Affiliation |
R.G.G.P.G ayu. College and hospital |
| Address |
H.O.D reader P.G. dept. Of kayachikitsa R.G.G.P.G ayu. College and hospital paprola kangra H.P.
V.P.O. Kharanal Paprola Distt. Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418312324 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CSIR |
| Address |
CSIR New Delhi HCP0035 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| RGGPG Ayurvedic College Paprola |
Rajeev Gandhi Government Post Graduate Ayurvedic College Paprola Dist. Kangra H.P. 176115 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr anjana mishra |
Rajeev Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
R.G.G.P.G AYU. COLLEGE AND HOSPITAL distt. Kangra hp 176115
Kangra
HIMACHAL PRADESH |
9418312324
dranjana269@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC R.G.G.P.G ayu. College and hospital paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G300||Alzheimers disease with early onset. Ayurveda Condition: MANAS ROG, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Nutraceutical formulation, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Mild and moderate subjective symptoms of memory impairment.
2.Age of patient :50-80 years.
3.A previous diagnosis of early dementia or MCI with a score of >9 and <23 on the mini-mental state examination
4.The ability and willingness to provide informed consent. |
|
| ExclusionCriteria |
| Details |
1.A screening MMSE score of <9(indicating severe memory impairment.)
2.Known neuropsychiatric conditions.
3.Uncontrolled hypertension or diabetes mellitus.
4.Drug dependence or addiction.
5.Use of alcohol, psychotropic drugs or alternative
medicines for memory.
6.Subject with concurrent Hepatic dysfunction.
7.Subjects suffering from major systemic illness necessitating long term drug use (R.A.,T.B.)
8.Any other condition which the investigator thinks may compromise the safety.
9.Subjects with established diagnosis of CAD requiring any procedure in next 6 months -angioplasty or bypass surgery or any other clinically significant cardiovascular disease.
10.Already known hypersensitivity to any interventional drug.
11.Patients who have participated in any clinical trial during past 6 months.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Mini-mental examination score from 1st day i.e. baseline to 12th week. |
84 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in SF-36 Health Survey score from 1st day i.e. baseline to 12th week. |
12 weeks |
|
|
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" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2022 |
| 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 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Will be published after completion of study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Data will be published after completion of trial as soon as possible . Two groups will be studied and the outcome of study will be analyzed with appropriate statistical tools. |