| CTRI Number |
CTRI/2025/12/099993 [Registered on: 31/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two herbal syrup for school going children with Vataj -Kaphaj Jwar |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Haridradi syrup verus Nagaradi syrup in the management of Vata -Kaphaj Jwar among school-going children A-RCT |
| 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 Monali Khobragade |
| Designation |
Phd Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College and hospital and Research centre,salod, hospital |
| Address |
Balrog Department,(OPD) of ,Mahatma Gandhi Ayurved College and Hospital and Research Centre Salod Swangi Wardha
Balrog Department (OPD)of Mahatma Gandhi Ayurved College and Hospital and Research Centre, Salod, Swangi, Wardha.
Nagpur
MAHARASHTRA
440009
India |
| Phone |
09284641135 |
| Fax |
|
| Email |
drmonalikhobragade04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renu Rathi |
| Designation |
HOD and Professor |
| Affiliation |
Mahatma Gandhi Ayurved College and hospital and Research centre,salod, hospital |
| Address |
Balrog Department, (OPD) of Mahatma Gandhi Ayurved College and Hospital and Research Centre Salod Sawngi Wardha-440009
Balrog Department,(OPD) of Mahatma Gandhi Ayurved College and Hospital and Research Centre, Salod, Sawngi, Wardha.
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9011058302 |
| Fax |
|
| Email |
renu.rathi@dmimsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monali Khobragade |
| Designation |
Phd Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College and hospital and Research centre,salod, hospital |
| Address |
Balrog Department (OPD) of Mahatma Gandhi Ayurved College and Hospital and Research Centre Salod Swangi Wardha
Balrog Department, (OPD) of Mahatma Gandhi Ayurved College and Hospital and Research Centre, Salod Swangi, Wardha.
Nagpur
MAHARASHTRA
440009
India |
| Phone |
09284641135 |
| Fax |
|
| Email |
drmonalikhobragade04@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College |
| Address |
Mahatma Gandhi Ayurved College and Hospital Research Centre, Salod Sawangi, Wardha, Pincode - 4420001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Monali Khobragade |
Vata-Kaphaj Jwar |
Balrog Department (OPD)of Mahatma Gandhi Ayurved College and Hospital and Research Centre Salod Swangi Wardha
Wardha
MAHARASHTRA |
09284641135
drmonalikhobragade04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central ethics committee on human research Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z889||Allergy status to unspecified drugs, medicaments and biological substances status. Ayurveda Condition: VataK, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nagaradi Kashayam , Reference: Sushruta Samhita , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: Dietary Changes according to prakriti of patients | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haridradi Kashayam , Reference: Sushruta Samhita , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Lukewarm Water ), Additional Information: Dietary Changes according to prakriti of patients |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants whose parents are willing to give written informed consent and children’s
assent to enroll in the study will be selected.
2. Participants will be selected irrespective of Prakriti, Desha, Kala, Bala, Sex, religion,
and socioeconomic status & age group between 6 years to 12 years of age suffering
from Vataj Kaphaj Jwar (Cold, Cough, and Fever).
3. Participants will be selected from the participant’s parents who are ready to give follow
ups and their co-operation regularly on mobile calls.
4. Participants will be diagnosed based on the lakshan of Vataj Kaphaj Jwara as per
Ayurvedic classical text.
5. Participants will be selected from a range of temperatures less than 1030 F & with a
complaint of fever of less than 3 days. |
|
| ExclusionCriteria |
| Details |
1. Participants suffering from developmental disorders.
2. Participants suffering from psychiatric illness and on medication.
3. Participants below 6 years of age.
4. Participants were not willing to participate in the study.
5. Participants from LRTI (Lower Respiratory Tract Infection ) and T.B., SAM (Severe
Acute Malnutrition), and MAM(Moderate Acute Malnutrition), Systemic illness.
6. Participants having more than 1030 F will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study may provide relief from Vata-Kaphaj Jwar |
At the end of 2nd week (14 Days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| May Suppress the vata Kaphaj jwar by Haridradi Kashayam than Nagaradi kashyam in School going children |
At the end of 2nd week(14 days) |
|
|
Target Sample Size
|
Total Sample Size="188"
Sample Size from India="188"
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)
|
15/01/2026 |
| 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="2"
Months="0"
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
|
To date, minimal studies are available on Vata-Kaphaj Jwar in school-going children. Most of the study works on Daihika Jwar Chikitsa in children but not on Vata- Kaphaj Jwar in school going children. I was unable to find a parallel arm comparative study on internal intervention in both groups. As Vata-Kaphaj Jwar influences on imbalances of Vata-kapha dosha leads to Jwara and other lakshan’s no researcher worked on a comparative of two drugs and their efficacy in recurrent flu during seasonal changes. Most of the studies are single-arm studies with Kashyam which is not feasible to perform in children due to palatable issues. Ancient Ayurvedic formulations will help to improve their immunity to fight against recurrent viral bacterial infection in school-going children. There is a recurrent use of antibiotics in viral and bacterial fever during seasonal changes which leads to resistance towards antibiotics and their side effects in children. (19) There is insufficient prevalence of this condition across various pediatric populations. It is necessary to provide more thorough explanations and research on the particular signs and symptoms of Vata-Kaphaj Jwar in children. Studies that explore the underlying mechanisms can help in better understanding and treatment. There is a significant lack of high-quality clinical trials evaluating the efficacy and safety of Ayurvedic treatments, such as Panchakola Kashaya, for Vata-Kaphaj Jwar in children. Research on the accessibility and cost-effectiveness of Ayurvedic treatment for Vata-Kaphaj Jwar in different socioeconomic contexts is necessary to ensure equitable healthcare. (20)Longitudinal studies that follow children diagnosed with Vata-Kaphaj Jwar over time are lacking. These studies could provide insights into the effectiveness of treatments. Research on preventive strategies in Ayurveda, such as dietary and lifestyle modifications, and their long-term impact on preventing Vata Kaphaj Jwar is also limited. There is a need for research using robust methodologies that can withstand scientific scrutiny. This includes randomized clinical trials, systematic reviews, addressing these research knowledge gaps requires a concerted effort from the medical and research community. By conducting well-designed studies and fostering interdisciplinary collaboration, we can improve our understanding and management of Vata-Kaphaj Jwar in children, ultimately leading to better health outcomes. So, in this study, I am trying to evaluate the efficacy of Haridardi syrup vs Nagaradi syrup in school-going children its management of Vata- Kaphaj Jwar 4.Research Question Is Haridradi syrup non -inferiorly efficacious than Nagaradi syrup i. . India contributes to 18% of the global population, with
severe acute respiratory infection (SARI) as one of the prominent causes of mortality in
children >5 years(4) |