| CTRI Number |
CTRI/2024/08/071857 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Tamaka shwasa |
|
Scientific Title of Study
|
Comparative Clinical Study to Evaluate the Effect of Karchura arka (Curcuma zedoaria Rosc.) and Parnayavani arka (Coleus aromaticus Benth.) in Tamaka shwasa vis-a-vis Bronchial Asthma |
| 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 Nagashree S |
| Designation |
PG scholar |
| Affiliation |
Government Ayurveda Medical College |
| Address |
Department of Dravyaguna Government Ayurveda Medical College near Anand Rao Circle Dhanwantari road Majestic Bengaluru
Bangalore
KARNATAKA
560009
India |
| Phone |
9591910509 |
| Fax |
|
| Email |
nagashrees98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M S Veena |
| Designation |
Professor |
| Affiliation |
Government Ayurveda Medical College |
| Address |
Department of Dravyaguna Government Ayurveda Medical College near Anand Rao Circle Dhanwantari road Majestic Bengaluru
Bangalore
KARNATAKA
560009
India |
| Phone |
9591030698 |
| Fax |
|
| Email |
mullur.vina@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M S Veena |
| Designation |
Professor |
| Affiliation |
Government Ayurveda Medical College |
| Address |
Department of Dravyaguna vijnana Government Ayurveda Medical College near Anand Rao Circle Dhanwantari road Majestic Bengaluru
Bangalore
KARNATAKA
560009
India |
| Phone |
9591030698 |
| Fax |
|
| Email |
mullur.vina@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College near Anand Rao Circle Dhanwantari road Majestic Bengaluru 560009 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda Medical College |
| Address |
Government Ayurveda Medical College near Anand Rao Circle Dhanwantari road Majestic Bengaluru 560009 |
| Type of Sponsor |
Government 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 Nagashree S |
Government Ayurveda Medical College |
Department of Dravyaguna
Dhanwantari road near Anand Rao circle
Majestic Bengaluru 560009
Bangalore
KARNATAKA |
9591910509
nagashrees98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurveda Medical College near Anand Rao circle Dhanwantari road Majestic Bengaluru Karnataka 560009 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PARNAYAVANI, Reference: PRIYA NIGHANTU, Route: Oral, Dosage Form: Arka, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 15 Days, anupAna/sahapAna: Yes(details: -SUKHOSHNA JALA), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: KARCHURA, Reference: BHAVAPRAKASHA NIGHANTU, Route: Oral, Dosage Form: Arka, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 15 Days, anupAna/sahapAna: Yes(details: -SUKHOSHNA JALA), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having classical symptoms of Tamaka Shwasa with atleast 3 symptoms and for a duration of atleast 3 months are selected for the study
Subjects who are willing to be a part of research work and are ready to sign the written consent will be selected
Mild to Moderate condition according to GINA parameters
Peak Expiratory Flow Rate within 60 to 90 percentage
|
|
| ExclusionCriteria |
| Details |
Peak Expiratory Flow Rate less than 60 percentage
History of any Cardiac involvement Cyanosis
Uncontrolled Diabetes Mellitus and Hypertension
Pregnant and Lactating women
Any anatomical defect in airway and other complicated respiratory disorders like TB Emphysema Bronchiectasis Carcinoma etc
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of Subjective parameters will be done based on classical symptoms of Tamaka Shwasa
Assessment of Objective parameters will be done based on Auscultation Peak Expiratory Flow Rate
|
15days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Severity will be done Before Treatment After Treatment & during the Follow up |
22 days |
|
|
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)
|
11/08/2024 |
| 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
|
Tamaka Shwasa is charecterized as a disorder of Pranavaha srotas resulting from the imbalance of Vata Kapha doshas, which manifests symptoms like Peenasa Ghurghuraka shabdha etc. According to WHO, Global surveys have indicated that over 262 million individuals worldwide are affected by Bronchial Asthma with a Prevalence rate ranging from 2-5 percent in India. Upon assessing the breathing patterns and pathological alterations Bronchial Asthma closely mirrors the charecteristics of Tamaka Shwasa. The concept of Arka as a dosage form is widely used in modern times due to its reduced dosing requirements enhanced patient adherence and amplified potency. Given the higher prevalence of Asthma there is a growing need to diversify treatment options within the field of Ayurveda. In this context Arka Kalpana assumes a pivotal role due to its palatability and rapid assimilation compared to other formulations. The drugs Karchura and Parnayavani with their rich volatile components can indeed play a significant role in treating Tamaka Shwasa when prepared in the form of Arka. |