| CTRI Number |
CTRI/2025/05/086233 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Establishment Folklore Plant Garlic Vine As Medicine Assessed by Ayurvedic Parameters |
|
Scientific Title of Study
|
EVALUATION OF FOLK MEDICINAL PLANT
GARLIC VINE Mansoa alliacea (Desv. Ex Beauv.) A. Gentry |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishwa Joshi |
| Designation |
PG scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Dravyagun Department , Room no. 211, Parul Institute Of Ayurved
Parul University
Waghodia Vadodara
Dravyagun Department , Room no. 211, Parul Institute Of Ayurved
Parul University
Waghodia Vadodara
Vadodara
GUJARAT
380008
India |
| Phone |
9316181150 |
| Fax |
|
| Email |
vishwaa97826@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha Parmar |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved,
Parul University
Waghodia, Vadodara
Parul Institute of Ayurved,
Parul University
Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9724306523 |
| Fax |
|
| Email |
Rekha.parmar@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Vishwa Joshi |
| Designation |
PG scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Dravyagun Department , Room no. 211, Parul Institute Of Ayurved
Parul University
Waghodia Vadodara
Parul Institute of Ayurved,
Parul University
Waghodia, Vadodara
GUJARAT
391760
India |
| Phone |
9316181150 |
| Fax |
|
| Email |
vishwaa97826@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dravyagun Department , Room no. 211, Parul Institute Of Ayurved
Parul University
Waghodia Vadodara |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurved |
| Address |
Room No 211 Dravyagun Department Parul Institute of Ayurved Parul University Waghodia Vadodara Gujarat |
| Type of Sponsor |
Private 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 Vishwa |
Parui Ayurved Hospital |
Room 209
Dravyaguna Department
Parul Institute Of Ayurveda
Parul University Limda Waghodiya Vadodara
Vadodara
GUJARAT |
9316181150
vishwaa97826@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIA IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age Between 18 to 50 years, including both gender having no specific major diseases. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Garlic Vine, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Garlic Vine, Reference: NA, Route: Oral, Dosage Form: Dravaka, Dose: 10(ml), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
volunteers from ayurvedic and non ayurvedic background are included having no history of present illness.
|
|
| ExclusionCriteria |
| Details |
Any major diseases and problem related senses are excluded. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate The Folklore Medicine Garlic Vine- Mansoa alliacea (Desv. Ex Beauv.) A. Gentry |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Authenticate The Rasa And Veerya of Garlic Vine And To Study Pharmacognostically And Phytochemically |
8 to 9 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
|
N/A |
|
Date of First Enrollment (India)
|
29/05/2025 |
| 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="1"
Days="30" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Folklore Medicine Garlic Vine Is Widely Used For Fever Pneumonia Like Disease So To Evaluate The Efficacy Of Drug It Is Selected To Authenticate As On The Basis Of Ayurvedic Parameters Like Rasa Guna Virya Vipak Among These Here Rasa And Virya Assessment Will Be Done According Previously Designed Proforma It Is Blind Randomized Study Where Two Groups Are Enrolled Both Having 15 Volunteers One Is From Ayurvedic Background And Another Is From Non Ayurvedic Background The Drug Is Cultivated In Botanical Garden Then Dried Leaf Powder Will Be Prepared And After Completion Of Pharmacognostical Study 2 Gm Of Powder Is Given To Each Volunteer Rasa Nirdharan Will Be Done By Two Methods As Nipat Method Will Be Done By Direct Perception Second Method Is Done By Taste Threshold Where Diluted Drug Is Given For Taste Analysis Then Virya Will Be Defined By Endothermic And Exothermic Reactions After Conclusion The Result Is Assessed And Rasa and Virya Is Defined |