| CTRI Number |
CTRI/2025/06/089039 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Devdarvyadi Churna in the management of Kaphaja Kasa. |
|
Scientific Title of Study
|
An Open Labelled Randomized Controlled Clinical Study to Evaluate The Efficacy of Devdarvyadi Churna and Vyaghri Churna in Management of Kaphaja Kasa W.S.R. to Chronic 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 Rivanshi Joshi |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul university AP Limda TAL Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9427539602 |
| Fax |
|
| Email |
joshirivanshi99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu r |
| Designation |
Professor , PhD in Kayachikitsa |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul university AP Limda TAL Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8160858967 |
| Fax |
|
| Email |
manu.r260022@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manu r |
| Designation |
Professor , PhD in Kayachikitsa |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul university AP Limda TAL Waghodia Vadodara Gujarat
GUJARAT
391760
India |
| Phone |
8160858967 |
| Fax |
|
| Email |
manu.r260022@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved ,Parul University,Ap-Limda,TAL-Waghodia, Vadodara,Gujarat, India-391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Faculty of Ayurved,Parul University,AP-Limda,TAL-waghodia,Dist-Vadodara,Gujarat,India-391760 |
| Type of Sponsor |
Private medical college |
|
|
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 Rivanshi Joshi |
Parul Ayurved Hospital |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul university AP Limda TAL Waghodia Vadodara Gujarat
Vadodara
GUJARAT |
09427539602
joshirivanshi99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Devdarvyadi Churna, Reference: Charak chikitsa sthana chapter 18, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vyaghri Churna, Reference: astanga Hridaya uttar sthana chapter 40, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Chronicity From 3 months to 2 Consecutive Years
Patients having symptoms of Chronic Bronchitis copious and purulent sputum and frequent episodes of respiratory insufficiency
Patient willing to sign the informed consent and can participate in the study procedure
Patients having FEV1 between 50% to 80% |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women.
Immunocompromised status such as HIV, Tuberculosis, Cancer etc.
History of upper or lower respiratory tract infection, within the previous 30 days.
Subjects suffering from Acute Bronchitis.
K/C/O pneumonia, plural effusion, pneumothorax, heart disease, secondary severe infection.
Patients with uncontrolled Hypertension and uncontrolled Diabetes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the Anti-inflammatory and expectorant effect of Devdarvyadi Churna in comparison with Vyaghri Churna in the management of Kaphaja Kasa on the basis of ESR, AEC.
|
2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Anti-inflammatory & expectorant effect of Devdarvyadi Churna in comparison with Vyaghri Churna in the management of Kaphaja Kasa on the basis of Spirometry, SGRQ. |
2 Months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="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 recent years, there has been a notable rise in respiratory diseases. According to the National Center for Health Statistics, 62 million cases of common cold and cough occur annually, and cough ranks as the fifth most common symptom for which medical care is sought. Chronic bronchitis affects about 9.5 million people, primarily those over 50 years old. In Ayurveda, Kasa (cough) is described as a disease, symptom, or complication. Kaphaja Kasa, a type of Ardra Kasa, is dominated by Kapha and Vata involvement and is comparable to chronic bronchitis due to similarities in symptoms like persistent productive cough. Chronic bronchitis involves inflammation of bronchi with sputum production for at least three months over two consecutive years and is linked to pollutants, smoking, and infections. If untreated, Kasa can lead to serious conditions like Shwasa (asthma) or Rajyakshma (tuberculosis). The Devdarvyadi Churna, mentioned by Acharya Charaka, contains herbs like Devdaru, Haritaki, Musta, and Pippali along with Madhu (honey), which help in pacifying Kapha and regulating Vata. With Ushna Veerya, Deepana, and Pachana properties, this formulation aids in digestion and relieves cough. Hence, this study aims to evaluate its efficacy in managing Kaphaja Kasa. |