| CTRI Number |
CTRI/2025/03/082804 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of pippalyadi churna in the management of Allergic bronchitis |
|
Scientific Title of Study
|
A comparativw clinical study to evaluate the therapeutic effect of pippalyadi churna and sitophaladi churna in the management of kaphaja kasa VIS-A-VIS Allergic bronchitis |
| 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 Bhuvaneshwari |
| Designation |
PG scholar |
| Affiliation |
Muniyal institute of ayurveda medical sciences, Manipal |
| Address |
Outpatient department of kayachikitsa, room no.4, ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi
Udupi KARNATAKA 576104 India |
| Phone |
8618641978 |
| Fax |
|
| Email |
shilparathod772@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pramod Shet B |
| Designation |
Professor |
| Affiliation |
Muniyal institute of ayurveda medical sciences, Manipal |
| Address |
Outpatient department of kayachikitsa, room no.4, ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi
Udupi KARNATAKA 576104 India |
| Phone |
7204557179 |
| Fax |
|
| Email |
pramodshetb@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bhuvaneshwari |
| Designation |
PG SCHOLAR |
| Affiliation |
Muniyal Institute Of Ayurveda Medical Science |
| Address |
Outpatient department of Kayachikitsa, Room no.4, Ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi
Udupi KARNATAKA 576104 India |
| Phone |
8618641978 |
| Fax |
|
| Email |
shilparathod772@gmail.com |
|
|
Source of Monetary or Material Support
|
| Muniyal institute of ayurveda medical sciences, manipal, udupi, karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
Muniyal institute of ayurveda medical sciences |
| Address |
Outpatient department of kayachikitsa, room no.4, ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi, karnataka, India - 576104 |
| 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 Bhuvaneshwari |
Muniyal institute of ayurveda medical sciences, Manipal |
Outpatient department of kayachikitsa, room no.4, ground floor, Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, udupi Udupi KARNATAKA |
8618641978
shilparathod772@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| muniyal institute of ayurveda institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J411||Mucopurulent chronic bronchitis. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sitopaladi Churna, Reference: Charaka samhitha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pippalyadi churna, Reference: Gada nigraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical symptoms of kaphaja kasa bahula, madhura, shwet snigdha, nishtiva, ghana kapha, gourava, aruchi, shirashoola, swarabheda, peenasa, utklesha, mandagni
Patients aged between 20-60 years of either gender.
Allergic bronchitis ranges from mild to moderate |
|
| ExclusionCriteria |
| Details |
Diagnosed patients with DM/HTN
Diagnosed patients with Emphysema,CHD, Pnuemothorax, Septicemia, Haemoptysis, pneumonia, TB, Interstitial lung diseases
Pregnant women and lactating mother
Diagnosed patients with covid-19 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the respiratory complaints |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="3" Days="15" |
|
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
|
Kasa is one of the most common diseases affecting the pranavaha srotas. If not treated, it may lead to dreadful diseases like Shwasa and Kshaya. According to the Acharyas, kasa is of 5 types, Kaphaja kasa being one among them. Kasa (cough) is the disease or symptom of respiratory tract occurring due to obstruction of Vata Dosha and its reverse movement and also a symptom of many other diseases. Kaphaja Kasa is dominated by Vata and Kapha and its nidana, samprapti, lakshanas, upadravas, and chikitsa are explainedin the classicS The lakshanas of kaphaja kasa are similar to Allergic bronchitis or Chronic bronchitis & it has become more prevalent these days because of cigarette smoking. environmental pollution, occupational hazrds. In kaphaja kasa lakshanas are bahula, madhura, snigdha, swetha, nishtiva, ghana kapha, aruchi, gaurava, shirashoola, swarabheda, peenasa, kantha kandu, utklesha etc. Early intervention is necessary in case of kasa as it is a potential nidanarthkara vyadhi (disease itself become causative factor for other disease) to produce kshaya i.e depletion of bodily tissues/ dhatus. According to Ayurveda Chikitsa Siddhant, the prime treatment for Kaphaja Kasa is Nidana Parivarjana and the formulations which are Vata-kapha hara, Vatanulomana Agnideepana, Aama pachana and Srotoshodhaka. Keeping these points in mind an attempt is made to achieve these goals through Ayurvedic medicine. Pippalyadi churna is taken for the clinical study by considering the qualities of ingredients and cost effectiveness. |