| CTRI Number |
CTRI/2024/09/074523 [Registered on: 30/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Patient having symptoms of bronchial asthma will be selected and odd even randomization will be done and add on effect of bharangiharitaki aval rha will be observed in patients and eosinophil count will be observed .
|
|
Scientific Title of Study
|
Randomised clinical trial to assess add on effect of bharangiharitaki avaleha in tamak shwasa(bronchial asthma) with special reference to eosinophil count.
|
| 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 Namrata Jayprakash shinde |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College and Hospital |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur, Department of Rognidan , Division No 1 , Room no 1 tal Walwa Dist Sangli
Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8530450224 |
| Fax |
|
| Email |
namujshinde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandip patil |
| Designation |
Associate professor |
| Affiliation |
LRP Ayurvedic Medical College and Hospital |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur, Department of Rognidan , Division No 1 , Room no 1 tal Walwa Dist Sangli
Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9823531537 |
| Fax |
|
| Email |
sandipkanase87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandip patil |
| Designation |
Associate professor |
| Affiliation |
LRP Ayurvedic Medical College and Hospital |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur, Department of Rognidan , Division No 1 , Room no 1 tal Walwa Dist Sangli
Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9823531537 |
| Fax |
|
| Email |
sandipkanase87@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital and Research Centre, Islampur. taluka Walwa Dist Sangli State Maharashtra Country India Pincode 415409 |
|
|
Primary Sponsor
|
| Name |
Dr.Namrata Shinde |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur, Department of Rognidan , Division No 1 , Room no 1 tal Walwa Dist Sangli
Sangli
|
| 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 Namrata shinde |
LRP Ayurvedic Medical College and HospitAl |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre , Department of Rognidan , Division no. 1 , Room no 1 , Islampur Sangli
Sangli MAHARASHTRA
Sangli
MAHARASHTRA |
8530450224
namujshinde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Loknete Rajarambapu Patil Ayurved Mahavidyalay Sangli Institutional Ethical 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: TAMAKASVASAH, (2) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH, (3) 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: Bharangiharataki, Reference: Yogratnakar, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: Bharangiharataki, Reference: Yogratnakar, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablet Deriphylline | Combination of etophylline and theophylline will be given.
Duration - 30 days
Dose -100 mg bid |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient having tamak shwasa symptoms like shwasakrichtta, kasa(cough) lalate sweda (sweating over forehead, asinolabhate saukhyam (comfortable in sitting position), vamathu prayaha (spitting again and again), anidra (insommnia)
2) Patient in avega avastha.
3) Patient on drug etofylline (23 mg) + theophylline (77 mg) BD
4) Sex: irrespective of sex
5) Patient of age group 18-50 will be included |
|
| ExclusionCriteria |
| Details |
1) Patient with bronchiectectasis, emphysema, infective neoplasmic disease of Respiration.
2) Known case of tamak shwasa taking treatment more than 3 years.
3) Patient on drug other than etofylline (23 mg) + theophylline (77 mg) BD.
4) Patient with systemic disorder.
5) Patient in vega avasta.
6) Pregnancy, Lactating Mother. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO STUDY ADD ON EFFECT OF BHARANGIHARITAKI AVALEHA IN TAMAKA SHWASA (BRONCHIAL ASTHMA) WITH SPECIAL REFERENCE TO EOSINOPHIL COUNT |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study tamak shwasa according to ayurvedicliterature.
2) To study bronchial asthma.
3) To study eosinophil count, respiratory rate, peak expiratory flow rate.
4) To study relief in tamak shwasa by using bharangiharitaki avaleha.
5) To study changes in eosinophil count, respiratory rate, peak expiratory flow rate in tamak shwasa by using bharangiharitaki avaleha. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/10/2024 |
| 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
|
Bronchial asthma is the common cause of death in rural india. Patients suffering from infective respiratory diseases such as tuberculosis, pneumonia can be cured after treatment but a sizeable number of patients continue to suffer from fibrotic sequel of these diseases. Apart from these there is going to be a large group of potential respiratory patients in future. They are persons exposed to smoke, pollution and various types of occupational dust which are more prone to develop bronchial asthma and therefore constitute the group of potential respiratory patients. ​This alarming raise in the prevalence of tamak shwasa can be accounted to factors such as atmospheric pollution, rapid environmental changes, adaptation of newer dietetic preparations and tremendous psychological stress. In ayurveda it is among five types of shwasa roga, and sometimes is considered to be satisfactorily treatable disease. The clinical manifestations show high recurrence pattern. ​Therefore, the management criteria should be addressed to quality improvement in the life of patients. ​Ayurveda can give promising result to the patient either by adding rasayana and thus enhancing the vital capacity and resistance of the lung or can be adjuvant to present modern regimen for the management of tamaka shwasa by the quality of life of affected patients, this drug having ushna tikta and shwassthan karma may affect and reduces the symptoms and dose of ongoing drugs. ​Vata and kapha are the two key pathological factors involved in the samprapti of tamaka shwasa. Thus, more and more research work is the need of the day either in bringing about a cure for this illness or effective control. More than 200 works have been carried out on this topic in all over India in ayurveda field. Ayurveda has got many time-tested formulations for this condition. ​Clinically, patient’s eosinophil count and respiratory rate is increased, peak expiratory flow rate is lower. According to line of treatment of tamaka shwasa,so topic is selected bharangiharitaki avaleha which is having vata-kaphaghna and ushna property, any decrease in symptoms i.e. eosinophil count, respiratory rate and peak expiratory flow rate will be observed. The present study will be carried out to study add on effect of bharangiharitaki avaleha in tamak shwasa. |