| CTRI Number |
CTRI/2025/05/086165 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Experimental Study on the Effectiveness of Jaya Vati in Treating Navjwara (Fever) |
|
Scientific Title of Study
|
A Pharmaceutico-Analytical And Experimental Exploratory
Trial Of Jaya Vati In The Management Of Navjwara (Fever)
|
| 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 Niha Khilzzi |
| Designation |
MD Scholar |
| Affiliation |
PGIA Jodhpur |
| Address |
3-D-1, Vigyan Nagar Kota Rajasthan 324005
Rasashastra and Bhaishajya Kalpana PGIA Dr S R Rajasthan Ayurved University Jodhpur Rajasthan
342037
Jodhpur
RAJASTHAN
324005
India |
| Phone |
9785971352 |
| Fax |
|
| Email |
nihakhilzzi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Govind Sahay Shukla |
| Designation |
Professor |
| Affiliation |
PGIA Jodhpur |
| Address |
Rasashastra and Bhaishajya Kalpana PGIA Dr S R Rajasthan Ayurved University Jodhpur Rajasthan
PGIA Dr S R Rajasthan Ayurved University Jodhpur Rajasthan
342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8769058254 |
| Fax |
|
| Email |
drgovindshukla@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niha Khilzzi |
| Designation |
MD Scholar |
| Affiliation |
PGIA Jodhpur |
| Address |
Rasashastra and Bhaishajya Kalpana PGIA Dr S R Rajasthan Ayurved University Jodhpur Rajasthan
342037
PGIA Dr S R Rajasthan Ayurved University Jodhpur Rajasthan
342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
09785971352 |
| Fax |
|
| Email |
nihakhilzzi@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIA Dr S R Rajasthan Ayurved University Karwar Nagaur road Jodhpur Rajasthan 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Jodhpur Rajasthan |
| Address |
PGIA Dr S R Rajasthan Ayurved University Jodhpur Rajasthan
342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Niha khilzzi |
3-D-1 Gandhi Grah Vigyan Nagar Kota Rajasthan 324005 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Niha Khilzzi |
Sanjeevani Hospital |
Room No. 10 PGIA Dr
S R Rajasthan Ayurved
University Jodhpur
Rajasthan 342037
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
09785971352
nihakhilzzi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R688||Other general symptoms and signs. Ayurveda Condition: JVARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jaya Vati, Reference: Rasatarangini in the 24thTarang vishopavishadhi vigyaanam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: ushn jal), Additional Information: NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient who had history of 0to7 days of Fever will also be included
Patients of Jwara who exhibits the temperature between the ranges of 100.4to104°F |
|
| ExclusionCriteria |
| Details |
Age less than 18 and greater than 60 years
Pregnant and lactating mother
Patient having any serious illness like cardiovascular disease, Hypotension malignancy
Fever associated with other complication and severe vomiting
Fever with long duration other than Navjwara like Tuberculosis and Typhoid etc
Known cases of Dengue Haemorrhagic Fever
Fever with Chickenpox Measles Smallpox Swine Flu |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change In Subjective And Objective Parameter |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in quality of life of patient |
7 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="0"
Months="0"
Days="7" |
|
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
|
Ayurveda, an ancient system of medicine based on the Vedas, emphasizes holistic health. A branch called Rasa Shastra and Bhaishajya Kalpana focuses on herbal and herbo-mineral remedies. Jaya Vati, an herbal formulation mentioned in Rasatarangini by Acharya Sadanand Sharma, is used to treat Jwara (fever), considered the "king of diseases" in Ayurveda. It contains ingredients like Shuddha Vatsanabha, Haridra, Shunthi, Maricha, Pippali, Vidanga, Nimba, Musta, and Jayanti mool, all known for treating fever.
While NSAIDs are commonly used for fever, they come with side effects, highlighting the need for safer alternatives. Vatsanabha, a key ingredient in Jaya Vati, has antipyretic and diaphoretic properties, helping reduce fever. This study aims to evaluate Jaya Vati’s antipyretic effects through experimental and clinical studies. |