| CTRI Number |
CTRI/2024/10/075065 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical efficacy of aromatherapy in enhancing Smriti (Memory) |
|
Scientific Title of Study
|
Open label single arm clinical trial on the efficacy of vacha (Acorus calamus Linn.) aromatherapy on smriti |
| 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 Spoorthi Prasad H M |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, Thanniruhalla, Hassan |
| Address |
Department of Kriya Shareera (Ayurveda Physiology),
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
8277537937 |
| Fax |
|
| Email |
hmspoorthi28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagaraj Kamath |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, Thanniruhalla, Hassan |
| Address |
Department of Kriya Shareera (Ayurveda physiology),
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7019148632 |
| Fax |
|
| Email |
nagaraj.kamath1989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Spoorthi Prasad H M |
| Designation |
Post graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, Thanniruhalla, Hassan |
| Address |
Department of Kriya Shareera (Ayurveda Physiology)
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
8277537937 |
| Fax |
|
| Email |
hmspoorthi28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, Thanniruhalla, Hassan-573201, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Spoorthi Prasad H M |
| Address |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, Thanniruhalla, Hassan-573201, Karnataka, India |
| 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 Spoorthi Prasad H M |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital,Hassan-573201 |
OPD-1,Prakrithi Analysis OPD, Department of Kriya Shareera, SDMCAH, Tanniruhalla,Hassan-573201
Hassan
KARNATAKA |
8277537937
hmspoorthi28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Aromatherapy- Inhalation of the odour of Vacha (Acorus calamus Linn.)from a bottle consisting 30g of drug in form of coarse powder at a distance of 5 cm from nostrils for 10 minutes twice daily (8:00 am and 8:00 pm), Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
•Vata Pradhana Prakrithi individuals with Alpa Smriti between the age of 18-30 years irrespective of gender, religion and socio-economic status.
•Individuals who are willing to participate.
|
|
| ExclusionCriteria |
| Details |
•Suffering or on medication for any acute or chronic illness and Genetic disorders, Systemic illness and Congenital anomalies.
•Suffering from acute and recurrent upper respiratory tract infections.
•Suffering from chronic exacerbation like asthma, history of hypersensitivity and allergic reactions
•Suffering from psychotic disorders, cognitive impairments and neuro-psychological disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the Smriti (Memory) of Vata Pradhana Prakrithi individuals by use of Aromatherapy by Vacha (Acorus calamus Linn.) |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the Concentration & attention of Vata Pradhana Prakrithi individuals by use of Aromatherapy by Vacha (Acorus calamus Linn.) |
15 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2024 |
| Date of Study Completion (India) |
23/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Smriti is remembrance of things directly perceived; heard or experienced earlier. Memory is a
higher mental process in which information is encoded, stored and retrieved. Shiras is said to be
the Uttamanga, a site where higher intellectual functions take place. Nasa is the nearest route of
drug delivery to the Shiras and is called as the door to Shiras. Nasa is also considered as Indriya
Adhishtana for Gandha Ghrana. The therapeutic use of Gandha has been emphasized in
Ayurveda. Aromatherapy is one such therapeutic modality carried out using only the fragrances
or mere volatiles to cure or mitigate or to prevent disease, infection and indispositions by means
of inhalation. Olfaction enhances social and emotional interactions by odors and enriches
memory as limbic system is the common center for both olfaction and memory. Vacha (Acarus
Calamus Linn.) a Medhya drug which is aromatic and is indicated as a brain tonic in weak
memory. Vata Prakrithi individuals being Alpa Smriti have a lot of difficulties in managing the
day to day activities due to their poor memory and face problems in their educational or
professional career leading to anxiety, depression and mental stress. Swasthasya Urjaskara and
Aturasya Roganuth are the types of Bheshaja. Swasthasya Urjaskara signifies that certain Dravya
and Chikitsa can be used to improve the health condition of healthy individuals To know
whether Aromatherapy has an effect on Smriti, a clinical trial is required on this perspective in
the field of Kriya Sharir. Present study is a preliminary attempt to evaluate the effect of
Aromatherapy using Vacha coarse powder in Vata Prakrithi individuals with Alpa Smriti to
enhance Smriti. |