| CTRI Number |
CTRI/2021/10/037455 [Registered on: 21/10/2021] Trial Registered Prospectively |
| Last Modified On: |
16/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A RANDOMIZED OPEN LABELLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF MARSHA AND PRATIMARSHA NASYA WITH PURANA GHRITA IN INCREASING MEMORY RECALL IN UNDERGRADUATE STUDENTS. |
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABELLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF MARSHA AND PRATIMARSHA
NASYA WITH PURANA GHRITA IN INCREASING MEMORY RECALL IN UNDERGRADUATE STUDENTS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Unni Nilanjan |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Ved Vignan Maha Vidya Peetha, 21st KM, Kanakapura Road, Udayapura P.O., Bengaluru
21st KM, Kanakapura Road, Udayapura P.O.
Bangalore
KARNATAKA
560082
India |
| Phone |
8553458722 |
| Fax |
|
| Email |
doctornilanjan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Puttur |
| Designation |
Prof, HOD Dept of Panchakarma |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room Nom 305, Dept of Panchakarma, Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura Road, Udayapura P.O., Bengaluru
21st KM, Kanakapura Road, Udayapura P.O.
Bangalore
KARNATAKA
560082
India |
| Phone |
9448176059 |
| Fax |
|
| Email |
drganeshputtur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Unni Nilanjan |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Ved Vignan Maha Vidya Peetha, 21st KM, Kanakapura Road, Udayapura P.O., Bengaluru
21st KM, Kanakapura Road, Udayapura P.O.
Bangalore
KARNATAKA
560082
India |
| Phone |
8553458722 |
| Fax |
|
| Email |
doctornilanjan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hetha Organics LLP |
| Address |
Hetha Organics, LLP.,
Sikanderpur, Ghaziabad,
Uttar Pradesh - 200105 |
| 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 Unni Nilanjan |
Sri Sri College of Ayurvedic Science & Research Hospital |
Room No. 8,
Department of Panchakarma,
Sri Sri College of Ayurvedic Science & Research Hospital,
21st KM, Kanakapura Road, Udayapura P.O., Bangalore - 560082
Bangalore
KARNATAKA |
8553458722
doctornilanjan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To improve memory recall |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Marsha Nasya |
Nasya with 8 bindu pramana Purana Ghrita on either nostril for 7 days |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Pratimarsha Nasya |
Nasya with 2 bindu pramana Purana Ghrita on either nostril for 28 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fit for Marsha nasya.
Subjects fit for Pratimarsha nasya.
Subjects willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
Subjects who are unfit for Marsha nasya.
Subjects who are unfit for Pratimarsha nasya.
Subjects with existing Cognition deficit conditions or Learning disability.
Subjects with systemic illness such as Diabetes Mellitus, Cancer, Hypertension, Epilepsy.
Subjects with Mini Mental State Examination scores below 24.
Pregnant and Lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Ray Auditory Verbal Learning Test score |
0th, 7th, 14th, 21st, 28th, 35th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effect of Pratimarsha nasya with Purana ghrita in increasing memory recall.
2. To evaluate the effect of Marsha nasya with Purana ghrita in increasing memory recall.
3. To compare the effect of Pratimarsha nasya and Marsha nasya with Purana ghrita in increasing memory recall. |
0th, 7th, 14th, 21st, 28th, 35th days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/10/2021 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Memory retention and recall play a vital role in the process of cognition and learning, especially among students. Poor memory recall or forgetfulness is a common complaint among the students’ community. This problem seemed to exist even in earlier ages as indicated by the texts in Ayurveda, in which the answers to this problem is mentioned. Acharyas have mentioned many formulations that help in improving smriti, the ability to recall stored information. Previous studies show a significant effect of both Marsha and Pratimarsha nasya in influencing memory. There are previous studies done to ascertain ability to improve memory recall of Marsha nasya with Brahmi ghrita6. However, the present study evaluates the comparative efficacy of Marsha and Pratimarsha nasya considering the ease of administration, observation (relaxed rules and regimen), and non-complicated approach. Due to this reason, Pratimarsha nasya can greatly contribute to improve memory recall. 1. To evaluate the effect of Pratimarsha nasya with Purana ghrita in increasing memory recall. 2. To evaluate the effect of Marsha nasya with Purana ghrita in increasing memory recall. 3. To compare the effect of Pratimarsha nasya and Marsha nasya with Purana ghrita in increasing memory recall. 6.4. HYPOTHESIS NULL HYPOTHESIS (H0) - Both Pratimarsha nasya and Marsha nasya are equally effective in improving memory recall (There is no significant difference between Group A and Group B). H1 - The efficacy of Pratimarsha nasya is greater than the efficacy of Marsha nasya in improving memory recall. H2 - The efficacy of Marsha nasya is greater than the efficacy of Pratimarsha nasya in improving memory recall. |