| CTRI Number |
CTRI/2023/03/050456 [Registered on: 07/03/2023] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the efficacy of Kasantaka Churna with Madhu in the management of Kaphaja kasa w.s.r to Chronic Bronchitis : A Clinical trial |
|
Scientific Title of Study
|
An open label single arm clinical study to evaluate the efficacy of Kasantaka Churna with Madhu in the management of Kaphaja Kasa w.s.r to Chronic Bronchitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohammad Aamir |
| Designation |
MD (Ay.) Scholar |
| Affiliation |
Government Ayurvedic College |
| Address |
Department of Kayachikitsa Government Ayurved College ,Kadamkuan ,Patna
Patna
BIHAR
800003
India |
| Phone |
08862905807 |
| Fax |
|
| Email |
mohammadaamir486@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujeet Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College Patna |
| Address |
Department of Kayachikitsa
Government Ayurvedic College ,Kadamkuan ,Patna
Patna
BIHAR
800003
India |
| Phone |
9123272204 |
| Fax |
|
| Email |
drsujitkr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujeet Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College Patna |
| Address |
Department of Kayachikitsa
Government Ayurvedic College ,Kadamkuan ,Patna
Patna
BIHAR
800003
India |
| Phone |
9123272204 |
| Fax |
|
| Email |
drsujitkr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College,
Kadamkuan Patna
Near Buddha Murti ,Pin 800003 |
|
|
Primary Sponsor
|
| Name |
Dr Mohammad Aamir |
| Address |
MD (Ay.)Scholar Department of Kayachikitsa , Government Ayurvedic College Patna ,Bihar |
| 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 |
| Dr Sujeet Kumar |
Government Ayurvedic College Hospital Patna |
Department of Kayachkitsa ,Room no 9
Patna
BIHAR |
9123272204
drsujitkr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J418||Mixed simple and mucopurulent chronic bronchitis. Ayurveda Condition: KAPAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kasantaka Churna , Reference: Bhesajya Ratnavali , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having atleast 3 or more symptoms among the following
1.Pralipyamanen mukhena
2.Nishthivati ghanam kapham
3.Shirorujarta
4.Peenasa
5.The Cases having the symptoms suggestive of Chronic airway obstruction,cough,with expectorations of more than 2 years duration
6.Diagnosed Cases of Chronic Bronchitis .
and Grade I to IV Severity level according to GOLD criteria-modified Global initiative for Chronic Obstructive Lung Disease. |
|
| ExclusionCriteria |
| Details |
history of diseases like
1.Bronchial Asthma
2.Pulmonary Tuberculosis
3.Suppurative lung disease
4.Systemic Hypertension
5.CAHD,Primary Pulmonary Hypertension
6.Valvular Heart disease
7.Sleep Apnoea syndrome
8.Pregnant ladies & lactating ladies were also excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Symptoms of Kaphaja Kasa |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Kaphaja Kasa |
1 year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2023 |
| Date of Study Completion (India) |
16/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
kaphaja kasa is a disease of Pranavaha Srotas ,is a type of kasa where early intervention is of paramount importance in the field of medicine and can turn heads up ,if neglected or mismanaged as it may result in poor prognostic condition .Chronic Bronchitis is a form of Chronic obstructive pulmonary disease afflicting the cardinal symptom of having cough with sputum for at least 3 consecutive months for successive 2 years .The clinical features of kaphaja kasa according to Samhitas are Bahula Madhura Snigdha Ghana Nishtivana ,Mandagni,Aruchi,Chardi,Peenasa,Utklesha,Gourava,Lomharsha,Ashyamadhuram,kleda,etc .After considering these aspects ,present study has been designed to evaluate the efficacy of Kasantaka Churna in the management of Kaphaja Kasa with special reference to Chronic Bronchitis . |