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CTRI Number  CTRI/2024/11/076194 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 26/10/2024
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   Evaluate the efficacy of Rasnadi Yog in the management of Kaphaj Kasa in children. 
Scientific Title of Study   Randomized Controlled Clinical Study To Evaluate The Efficacy Of Rasnadi Yog In The Management Of Kaphaj Kasa In Children. 
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 Kavita K Fadnavis 
Designation  Assistant Professor 
Affiliation  C.S.M.S.S AYURVED COLLEGE CHH SAMBHAJINAGR  
Address  OPD NO.14 Balrog department,Chatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalya and Rugnalaya,Kanchanwadi Paithan Road,Aurangabad Maharashtra Aurangabad MAHARASHTRA 431011 India

Aurangabad
MAHARASHTRA
431011
India 
Phone  9552106984  
Fax    
Email  dr.kavitafadnavis@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrKavita K Fadnavis 
Designation  Assistant Professor 
Affiliation  C.S.M.S.S AYURVED COLLEGE CHH SAMBHAJINAGR  
Address  OPD NO.14 Balrog department,Chatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalya and Rugnalaya,Kanchanwadi Paithan Road,Aurangabad Maharashtra Aurangabad MAHARASHTRA 431011 India

Aurangabad
MAHARASHTRA
431011
India 
Phone  9552106984  
Fax    
Email  dr.kavitafadnavis@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrKavita K Fadnavis 
Designation  Assistant Professor 
Affiliation  C.S.M.S.S AYURVED COLLEGE CHH SAMBHAJINAGR  
Address  OPD NO.14 Balrog department,Chatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalya and Rugnalaya,Kanchanwadi Paithan Road,Aurangabad Maharashtra Aurangabad MAHARASHTRA 431011 India


MAHARASHTRA
431011
India 
Phone  9552106984  
Fax    
Email  dr.kavitafadnavis@gmail.com  
 
Source of Monetary or Material Support  
CSMSS Ayurvedic Mahavidyalaya and rugnalaya Kanchanwadi Chh sambhajinagar maharashtra India 431011 
 
Primary Sponsor  
Name  Pranjali Pandit Bhosale 
Address  Chatrapati Shahu Maharaj Sikshan Santhas Ayurved Mahavidyalaya and Rugnalaya kanchanwadi, Paithan Road, Aurangabad, 431011 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DRPranjali Pandit Bhosale   Chatrapati Shahu Maharaj Shikshan Sansthan Ayurved Mahavidyalaya and Rugnalaya  OPD NO.14 Balrog department,Chatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalya and Rugnalaya,Kanchanwadi Paithan Road,Aurangabad Maharashtra Aurangabad MAHARASHTRA 431011 India
Aurangabad
MAHARASHTRA 
9552106984

pranjalibhosale161@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC CSMSS Ayurved Mahavidyalaya And Rugnalaya chh sambhajinagar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: KASAH, (2) ICD-10 Condition:J398||Other specified diseases of upperrespiratory tract. Ayurveda Condition: KASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Rasnadi Yog , Reference: Harit Samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.14(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Sitopaladi Churna, Reference: Charak , Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.14(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: -
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Patients with classical signs and symptoms of Kaphaja Kasa.
Children in between the age group of 6 yrs to 16 years.
Patients will be included irrespective of gender, religion, socio- economic status, caste and food habits, etc. 
 
ExclusionCriteria 
Details  Case of Kasa other than Kaphaj Kasa.
Cough more than 7 days will be excluded..
Conditions & complications Related to systemic disorder 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mandagni(Loss of appetite)should be decreased.
Pinasa(Runny nose) should be decreased.
Kaphanishthiwan(cough with expectoration) should be decreased.
 
Baseline,3rd day,5th day,7th day 
 
Secondary Outcome  
Outcome  TimePoints 
Kasa Veg(cough bouts) should be decreased.  Baseline,3rd day,5th day,7th day 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   06/11/2024 
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="6"
Days="0" 
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  

In pediatric age group, dhatus are in Aparipakva avastha & has less immunity than adults. So, children are more prone to various diseases than adults. Children have Kapha dhatu bahulya and mostly manifested with respiratory disorders. As per the Ayurveda, Kasa occurs when Apana vayu is obstructed resulting in an increase in upward motion. Vitiation of Apan vayu with Udana vayu propels the air upwards and then out of the body. Types of Kasa are Vataj, Pittaj, Kaphaj, Kshayaj, Kshataja. Kaphaj kasa is one of the five varieties of Kasa.Kaphaj Kasa is mostly seen in pediatric population. Despite the Broad repercussion of cough in children, research work on this condition is minimal.Though it is not life threatening it interferes with daily routine activities. Recurrent attacks of cough make child especially school going child suffer and may have its adverse effect on concentration in studies .If neglected it will cause some serious ill effects hence treatment should be given at proper time.In modern medicine many pediatricians use cough syrups to provide the immediate relief of the symptoms in cough and cold. the immediate relief of the symptoms in cough and cold.In Ayurvedic classical texts many of the drugs have been described in the treatment of kasa. Rasnadi yog is herbal aushadhi kalp (herbal preparation) which works on smallest body channels called srotas and penetrate into the deepest tissue leads to samprapti bhanga of disease. It also prevents recurrence of the disease. Rasnadi yog is mentioned in Harit Samhita balrog adhyaya specially works on bala kasa. Whereas Sitopaladi churna is taken as control drug. 

A) Null Hypothesis-There Is no effect of Rasnadi Yog in Kaphaj Kasa.

B) Alternative Hypothesis-There is effect of Rasnadi Yog in Kaphaj Kasa.

The study will be conducted on 92 patients with 46 patients of trial group will be treated with Rasnadi Yog and other 46 patients of control group will be treated with Sitopaladi churna and the result will be conducted.


 
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