| CTRI Number |
CTRI/2024/11/077148 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How braham rasayan works in enhancement of memory |
|
Scientific Title of Study
|
A comparative open labelled randomized controlled study to evaluate the physiological efffect of Braham rasayan to Guduchi swaras on smriti(Memory) enhancement in healthy individuals. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Randhirkumar Vishwakarma |
| Designation |
MD Scholar Department of Kriya Sharir |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Institute for Ayurved Studies and Research Umri Road Sector 8
Kurukshetra Haryana 136118
Opd No 55A Department of Kriya Sharir Institute for Ayurved Studies
and Research Umri Road Sector 8 Kurukshetra Haryana 136118
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
8286013598 |
| Fax |
|
| Email |
vishwakarmarandhir67@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubha Kaushal |
| Designation |
MD Scholar Department of Kriya Sharir |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Institute for Ayurved Studies and Research Umri Road Sector 8
Kurukshetra Haryana 136118
Opd No 55A Department of Kriya Sharir Institute for Ayurved Studies
and Research Umri Road Sector 8 Kurukshetra Haryana 136118
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
8901184522 |
| Fax |
|
| Email |
drshubhakaushal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Randhirkumar Vishwakarma |
| Designation |
MD Scholar Department of Kriya Sharir |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Institute for Ayurved Studies and Research Umri Road Sector 8
Kurukshetra Haryana 136118
Opd No 55A Department of Kriya Sharir Institute for Ayurved Studies
and Research Umri Road Sector 8 Kurukshetra Haryana 136118
Kurukshetra
HARYANA
136118
India
Kurukshetra
HARYANA
136118
India |
| Phone |
8286013598 |
| Fax |
|
| Email |
vishwakarmarandhir67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies
and Research Umri Road Sector 8 Kurukshetra Haryana 136118
|
|
|
Primary Sponsor
|
| Name |
Dr. Randhirkumar Vishwakarma |
| Address |
Opd No 55A Department of Kriya Sharir Institute for Ayurved Studies
and Research Umri Road Sector 8 Kurukshetra Haryana 136118
|
| Type of Sponsor |
Other [Self] |
|
|
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 Randhirkumar |
Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana 136118 |
Opd No 55A
Department of Kriya
Sharir, Umri Road
Sector 8 Kurukshetra
Haryana 136118
Kurukshetra
HARYANA
Kurukshetra
HARYANA |
8286013598
vishwakarmarandhir67@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently Healthy Individuals. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Guduchi Swaras, Reference: (Charak Chikitsa ( 1/3), Route: Oral, Dosage Form: Swaras/ Juice, Dose: 48(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Braham Rasayan, Reference: Charak Chikitsa (1/1), Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Dugdh), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to participate in the trial.
2.Individuals with PGI memory score more less than 86. |
|
| ExclusionCriteria |
| Details |
1.Individuals below the age of 20 years and above the age of 30 years.
2.Individuals with PGI memory score more than 86.
3.Patient not willing to participate in the trial.
4.K/C/O Diabetes mellitus, hypertension, hyper or hypothyroidism and epilepsy etc.
5.Pregnant women and Lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in PGI memory score.
2. Assessment of memory by PGI memory scale. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Improvement in overall cognitive power. |
After 8 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)
|
01/12/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
60 apparently healthy individuals will be selected by Randomized method. (Alternate individual
will be selected) . Selected individuals will be divided into two equal groups. Groups will be divided as Group A and Group B with 30 individuals in each group. The memory of registered subjects will be assessed by using validated PGI memory scale Performa. Group A will get Braham Rasayan 12 gm OD and Group B will get Guduchi Swaras 1 Pal
in two divided dose for the span of two months for both the drugs. After intervention, the memory of Group A and group B individuals will be reassessed by using
validated PGI memory scale Performa. Generated data will be subjected to appropriate statistical test and conclusion will be drawn using
statistics as well as observation found in the study. |