| CTRI Number |
CTRI/2019/11/021927 [Registered on: 08/11/2019] Trial Registered Prospectively |
| Last Modified On: |
06/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Astaguna Manda and Jvarahara Phant Siddha Manda in jvara |
|
Scientific Title of Study
|
A Clinical Coparative Study to Assess The Effectiveness of Astaguna Manda And Jvarahara Phanta Siddha Manda In Jvara |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rangoli Rani Chouhan |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
National Institute of Ayurveda Department of Swasthavritta and yoga,OPD no.21 madhav vilas palace jorawar singh gate amer road Jaipur rajasthan 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
08561940709 |
| Fax |
|
| Email |
rangoli311990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Kashinath Samagandi |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7877444353 |
| Fax |
|
| Email |
kashisri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Kashinath Samagandi |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7877444353 |
| Fax |
|
| Email |
kashisri@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Near Jorawar Singh Gate Amer Road Jaipur Pin no 302002 |
|
|
Primary Sponsor
|
| Name |
National institute of Ayurveda |
| Address |
Near Jorawer singh gate, Amer road, jaipur-302002 |
| Type of Sponsor |
Government 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 |
| Rangoli Rani Chouhan |
National Institute Of Ayurveda |
Room No.21,Swassthavritta Arogyashala, Madhav Vilas, Jorawar Singh Gate,Amer Road
Jaipur
RAJASTHAN |
08561940709
rangoli311990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee of National Institute Of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B349||Viral infection, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Astaguna Manda |
Astaguna Manda will be administered to Jvara patients for 5-7 days and 2-3 times in a day dose according to appetite of the patient |
| Comparator Agent |
Jvarahara Phant siddha manda |
Jvarahara Phanta siddha manda will be administered for 5-7 days and 2-3 times in a day dose according to appetite of the patient to see the effect on jvara |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of pyrexia who exhibits the temperature between 99-102â—¦F |
|
| ExclusionCriteria |
| Details |
pyrexia associated with the other complaints like nausea vomiting, diagnosed cases of becterial origin pyrexia, Life threatening complaints like Dengue Hemorrhagic Fever |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Astaguna Manda May help to manage jvara and its symptoms |
7 days after first patient register |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The patient will be more energetic and quality of life may become better |
one month after one patient register |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2019 |
| Date of Study Completion (India) |
03/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Jvara is a common disease or a symptoms among the disease.It affects whole body and the organ of senses and also the mind. The symptoms of Jvara are elevated body temperature loss of appetite excessive thirst bodyache and pericardial discomfort .There is a tendency to a common men to buy the medicines like paracetamole or aceclofenac etc without consulting the doctor during the initial time of Jvara. If in the condition of Jvara the body temparature is less than 102 degree fahrenheit can be controlled by some diet modulation but some peoples are unaware of this and some wants to manage without medication.There is a open comparative study design of this study. Two groups will be taken in this study each group have 20 patients total 40 patients will be registered for trail one will served with astaguna manda and other will served with jvarahara phanta siddha manda. Total duration of trail is 7 days and follow up will be taken personally or telephonically. Total 40 patients of jvara were registered in trial and all 40 patients were completed the trial. Significant results were found in both groups. Both Astaguna Manda and Jvarahara Phanta Siddha Manda were found effective in the patients of Jvara. Study setting: Place of study i.e. NIA, Hospital Jaipur( outdoor patients) Total duration of Trial: 1 Month |