| CTRI Number |
CTRI/2024/11/076869 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Pathyadi Churna in management of chhardi in children |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study to evaluate the efficacy of Pathyadi Churna in the management of chhardi 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 |
VD. Rohit Ranchhod Patil |
| Designation |
MD Scholar kaumarbhritya |
| Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad |
| Address |
OPD No. 14 Balrog department, Chhatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi,Paithan road, Chh. Sambhajinagar
Aurangabad
MAHARASHTRA
431136
India
Aurangabad
MAHARASHTRA
431136
India |
| Phone |
7507888511 |
| Fax |
|
| Email |
patirohit7001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd K S Ratnaparkhi |
| Designation |
HOD and Professor |
| Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad |
| Address |
OPD NO.14 Balrog department,Chhatrapati Shahu Maharaj Shikshan Santhas Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Paithan road, Chh.Sambhajinagar
Aurangabad
MAHARASHTRA
431136
Aurangabad
MAHARASHTRA
431136
India |
| Phone |
9421771722 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd K S Ratnaparkhi |
| Designation |
HOD and Professor |
| Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad |
| Address |
OPD NO.14 Balrog department,Chhatrapati Shahu Maharaj Shikshan Santhas Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Paithan road, Chh.Sambhajinagar
Aurangabad
MAHARASHTRA
431136
MAHARASHTRA
431136
India |
| Phone |
9421771722 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurved Mahavidyalaya Kanchanwadi, Panthan road, Chhatrapati Sambhaji Nagar, Aurangabad, Maharashtra 431136 India |
|
|
Primary Sponsor
|
| Name |
VD Rohit Ranchhod Patil |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Paithan road,Aurangabad 431011 Chhatrapati Sambhajinagar |
| 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 |
| Vd Rohit Ranchhod Patil |
Chhatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya and Rugnalaya |
OPD NO. 14 Balrog department, Chhatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan road Aurangabad
431011
Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA |
7507888511
patilrohit7001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS Ayurved Mahavidyalaya and Rugnalaya Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K319||Disease of stomach and duodenum, unspecified. Ayurveda Condition: CARDIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mustadi churna, Reference: Charak samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 0.66(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 3 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathyadi churna, Reference: Bhavprakash samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 0.66(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 3 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 |
Age group between 6 to 16 years.
Patients irrespective of their gender, religion and socio economic class.
Patients having sign and symptoms of chhardi as mentioned in Ayurvedic text.
Patients suffering from chhardi for less than 2days with no dehydration. |
|
| ExclusionCriteria |
| Details |
Patient suffering from chhardi as upadrava of other disease
patient suffering from Atisar as well as Chhardi
Patients of known anatomical defects and metabolic disorders.
Patients with some and severe dehydration with chronic disorders like Cirrhosis of liver.
Patients with any other systemic disorders, neurological conditions like e.g. meningitis, malignancies , cerebral tumor
All surgical cases.
Sannipataj and Dvishtharthyogaj |
|
|
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
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prasek (Excessive salivation )
Aruchi (Anorexia)
Hrullas (Nausea) |
Baseline, 3rd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Chhardi vega
Dehydration |
Baseline , 3rd day |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
27/11/2024 |
| 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="0"
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
|
The kaumarbhritya is a branch of ayurveda which deals with study of childhood disease and their management. Chhardi is one of the common diseases of early growing age which resembles vomiting as per modern science.Chhardi (vomiting) or Emessis is the abnormal emptying of stomach and upper part of intestine through oesophagus and mouth. According to Ayurved chhardi is a disease of Annavaha strotas.
In Ayurveda there are five types of chhardi i.e. Vataj, Pittaj, Kaphaj, Sannipataj and Dvishtharthyogaj / Agantuja. Vitiated udan vayu along with vyan vayu brings the contents of stomach upward and expels through mouth. This condition is associated with vitiated Pitta and Kapha doshas. The drug to be used in child for suppression of vomiting within short duration as this may lead to severe complications in children. Some of which may be catastrophic and life threatening. Therefore determining the cause and treatment of child vomiting has major importance. RATIONALE OF STUDY
Chhardi is the commonest disease in children hence the need to be controlled by ayurvedic medicine without any side effects.
To break the pathology chhardi by agnideepana. The conventional treatment in modern medicine has side effects. Prochlorperazine should not be used in children due to high risk of extra pyramidal reaction, while antihistamine should be avoided due to sedation.
Metoclopramide has side effects like sedation ,dizziness ,diarrhoea, muscle dystonia (Specially in children.Long term use can cause parkinsonism ,galactorrhoea , and gynacomastia.
Ondensetron has side effects like - headache, mild constipation, or diarrhoea and abdominal discomfort. NULL HYPOTHESIS (H0)
Pathyadi churna is not effective in the management of chhardi in children. ALTERNATIVE HYPOTHESIS (H1)
Pathyadi churna is effective in the management of chhardi in children |