| CTRI Number |
CTRI/2021/12/039036 [Registered on: 29/12/2021] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study of Patoladi Kwath in Bronchial Asthma |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of Patoladi Kwath in Tamakshwasa with special reference to Bronchial Asthma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogesh T Kotangale |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College |
| Address |
Kayachikitsa Department
OPD Division,
OPD No.2
Ground Floor
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
Kayachikitsa Department
OPD Division,
OPD No.2
Ground Floor
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
|
| Fax |
|
| Email |
drytk@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radhika B Ghumare |
| Designation |
P.G. Scholar |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College |
| Address |
Kayachikitsa Department
OPD Division,
OPD No.2
Ground Floor
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
Kayachikitsa Department
OPD Division,
OPD No.2
Ground Floor
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
|
| Fax |
|
| Email |
radhikaghumare3042@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika B Ghumare |
| Designation |
P.G. Scholar |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College |
| Address |
Kayachikitsa Department
OPD Division,
OPD No.2
Ground Floor
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
Kayachikitsa Department
OPD Division,
OPD No.2
Ground Floor
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
|
| Fax |
|
| Email |
radhikaghumare3042@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sumatibhai Shah Ayurved college
Hadapsar
Pune |
|
|
Primary Sponsor
|
| Name |
Radhika B Ghumare |
| Address |
Kayachikitsa Department
OPD Division,
OPD No.2
Ground Floor
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune |
| 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 radhika Ghumare |
Saneguruji Arogya kendra |
Kayachikitsa OPD No.2
Ground Floor
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
Pune
MAHARASHTRA |
8999704737
radhikaghumare3042@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:J452||Mild intermittent asthma. Ayurveda Condition: Tamakshwasa, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Patoladi Kwath, Reference: Barat Bhaishjya Ratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: NO | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablet Deriphylline | 150 mg twice a day |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Diagnosed patients of Tamakshwasa in Avega-awastha.
2) Age: 20 to 70 Years.
3) Gender: Male & Female. |
|
| ExclusionCriteria |
| Details |
1) Pregnant Woman
2) Status Asthmatics & Cardiac Asthma
3) Patient of Tamakshwasa with secondary infections.
4) Patient suffering from systemic disorders like Tuberculosis, Emphysema, Cor Pulmonale, Diabetes etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Patoladi Kwath with Tab Derriphylline in Tamakshwas. |
2 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare the effect of Patoladi Kwath in Tamakshwasa on the basis of pulmonary function test.
2) To compare the effect of Patoladi Kwath in Tamakshwasa on the basis of Absolute Eosinophil Count. |
14 days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2022 |
| Date of Study Completion (India) |
15/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
publication after the completion of the clinical trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Difficulty in breathing or shortness of breath may be simply termed as Shwasa. It may be primary originating from respiratory system and secondary originating from other systems of the body but the Impact is on respiratory system. Bronchial asthma is chronic inflammatory system of airway. It leads to recurrent episodes of wheezing, breathlessness, tightness of chest and cough particularly at night or early in morning. As per Ayurveda, Shwasa is mainly caused by the Vata and kaphdoshas.Now a days with changing life style of the people pollution and environmental or climatic imbalance occur and cases of asthma increases day by day and in this fast life for instant relief modern science use steroidal therapy also. So, this is an attempt to introduce Ayurvedic medicines. • In modern medicines having side effects tachycardia, dryness of mouth and sweating. • Patol ,Yava, Shunthi, Pippali is having Vatanulomak and Kaphaghna effect so useful in Shwasa ,Kasa. • In modern medicine Nebulisation Bronchodilators, steroidal preparations are widely used, But they have many side effects i.e. headache, muscle cramps, nausea vomiting, diarrhea, suddenly noticeable heartbeat, tachycardia, dryness of mouth and sweat • Steroid causes changes in mood and behavior such as feeling irritable or anxious, high blood sugar or diabetes bone loss, stomach upset but Ayurvedic medicines avoid this effect. • Ayurveda not only treating disease but eliminating its root. • There is important role of immunity in Pranvaha Strotas. |