| 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
|
|
|
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
|
|
|
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, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm | Drug | Classical | | (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: - |
|
|
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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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