| CTRI Number |
CTRI/2025/04/084057 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to see the Effect of Kantakarayadi Yog in the Amaj jwara. |
|
Scientific Title of Study
|
A clinical Controlled trial on Kantakarayadi yog in the management of amaj jwara w.s.r. Enteric 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 |
Praveen gour |
| Designation |
MD Scholar |
| Affiliation |
state ayurvedic college and hospital lucknow |
| Address |
P.G.dept. of kaumarabhritya OPD NO.1 State Ayurvedic College and hospital, Lucknow
Lucknow
226003
UTTARPRADESH
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9997505074 |
| Fax |
|
| Email |
praveengour118@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Kumar gautam |
| Designation |
Lecturer |
| Affiliation |
state ayurvedic college and hospital tudiyaganj |
| Address |
P.G.dept. of kaumarabhritya OPD NO.1 State Ayurvedic College and hospital, Lucknow
Lucknow
226003
UTTARPRADESH
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9450361310 |
| Fax |
|
| Email |
gautamramesh09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Praveen gour |
| Designation |
MD Scholar |
| Affiliation |
state ayurvedic college and hospital |
| Address |
P.G.dept. of kaumarabhritya OPD NO.1 State Ayurvedic College and hospital, Lucknow
Lucknow
226003
UTTARPRADESH
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9997505074 |
| Fax |
|
| Email |
praveengour118@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital, Turiyaganj, tulsidas marg. Lucknow, Uttar Pradesh
Pincode 226004 |
|
|
Primary Sponsor
|
| Name |
state ayurvedic college and hospital lucknow |
| Address |
P.G.dept. of kaumarabhritya OPD NO.1 State Ayurvedic College and hospital, Lucknow
Lucknow
226003
UTTARPRADESH
India |
| 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 |
| Dr Praveen gour |
state ayurvedic college and hospital lucknow |
P.G.dept. of kaumarabhritya OPD NO.1 State Ayurvedic College and hospital, Lucknow
Lucknow
226003
UTTARPRADESH
India
P.G.dept. of kaumarabhritya OPD NO.1 State Ayurvedic College and hospital, Lucknow
Lucknow
226003
UTTARPRADESH
India
Lucknow
UTTAR PRADESH |
09997505074
praveengour118@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: AMAJAJVARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Cefixime | Cefixime 20mg/kg/day Per orally for 15days. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kantakaryadi yog, Reference: sharangadhar samhita madhyam khanda, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Range of temperature 98.7°Fto 104°F.
2. Children between age group of 6-16 years.
3. Patients were diagnosed on the basis of lakshanas of Sama jwara as per
ayurvedic classical text.
4. Complaint of fever less than 15 days.
5.parents/patients who are willing to participate trial. |
|
| ExclusionCriteria |
| Details |
1. Children less than 6 years and more than 16 years.
2. Sick child requiring aggressive management.
3. Patient diagnosed with dengue fever, viral fever, malaria, tuberculosis, appendicitis, intestinal perforation.
4.Parents/patients are not willing to continue the treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To control Amaj jwara in children.
2 To control symptoms like continuous fever, anorexia, indigestion, Heaviness in abdomen, loss of appetite, Bad taste in mouth, Tongue coated. |
during 15 day of clinical trial. we will access on 3rd, 7th ,15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of kantakaryadi yog in Amaj jwara W.S.R. Enteric fever.
2.To improve quality of life in children. |
After 30 day of clinical trial.We will access on 3rd day,7th day, 15th day,22nd day,30th day. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
21/04/2025 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Typhoid fever is most common in children. Typhoid fever is of bacterial origin is treated with antibiotics .Repeated use of antibiotics makes the patients resistant even to the newer antibiotics .Some herbal drugs with good potential against Salmonella typhi. Ayurveda is the ray of hope for such kind of Clinical condition. Therefore I select this trial. Clinical trial will be done on kantkarayadi yog in the management of Amaj jwara. Typhoid diagnosed children aged 6 to 16 years .Total duration of trial is 30 days .Clinical trial will be done in 2 Group.Kantakaraydi yog will be given for 15 days in 2 divided dose of Group A .Cefixime will be given for 15 days in Group B and 3 follow up will be performed during treatment and 2 follow up will be performed after 15 days of treatment. Kantkarayadi yog (vati) will be given by orally in 2 divided dose for 15 days . |