| CTRI Number |
CTRI/2024/07/071146 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate the efficacy of Bharangyadi Madhuka and Talishadi Churna in the management of Tamaka Shwas(Bronchial Asthma) |
|
Scientific Title of Study
|
An Open Labelled Comparative Clinical Study to Evaluate the Efficacy of Bharangyadi Madhuka and Talishadi Churna in the Management of Tamaka Shwas with special Reference to 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 Adbhut Kumar Mundhara |
| Designation |
PG scholar |
| Affiliation |
Institute For Ayurved Studies and Research |
| Address |
Room No 56, Department of Kayachikitsa
Kurukshetra
HARYANA
136118
India |
| Phone |
9215555255 |
| Fax |
|
| Email |
adbhut.k9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Kumari |
| Designation |
Professor & Chairperson |
| Affiliation |
Institute For Ayurved Studies and Research |
| Address |
Room No 56, Department Of Kayachikitsa
Kurukshetra
HARYANA
136118
India |
| Phone |
9671368058 |
| Fax |
|
| Email |
mehranilam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adbhut Kumar Mundhara |
| Designation |
PG scholar |
| Affiliation |
Institute For Ayurved Studies and Research |
| Address |
Room No 56, Department Of Kayachikitsa
Kurukshetra
HARYANA
136118
India |
| Phone |
9215555255 |
| Fax |
|
| Email |
adbhut.k9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved studies and research |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies and Research |
| Address |
Shri krishna Ayush University
Sector 8, Umri Road, Kurukshetra, Haryana, 136118 |
| 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 Adbhut Kumar Mundhara |
Institute For Ayurved Studies and Research |
Room No 56, Department Of Kayachikitsa
Kurukshetra
HARYANA |
9215555255
adbhut.k9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI KRISHNA AYUSH UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J453||Mild 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: Bharangyadi madhuka, Reference: Yoga ratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Madhusarpi), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Talishadi churna, Reference: Sharangdhar samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient willing for clinical trial and ready to give written Consent.
2 Patient between the age group of 25-60 years of either sex.
3 Patients fulfill the diagnostic criteria of Tamaka Shwasa (Bronchial Asthma).
4 Patients presented with cardinal features of Tamaka Shwasa as described in Ayurveda texts.
5 Diagnosed and confirmed cases of Tamaka Shawasa (Bronchial Asthma) on the basis of criteria given by NAEPP having Mild Intermittent and Mild Persistent type of Asthma |
|
| ExclusionCriteria |
| Details |
1 Patient not willing to Clinical Trial
2 Patients not fulfilling the Inclusion Criteria.
3 Patient having an Age below 25 and Above 60.
4 Patients having a medical history of CHF, CAD, Pulmonary hypertension, Diabetes Mellitus, Uncontrolled hypertension, CKD, and Autoimmune disorders.
5 During Pregnancy, Lactation period
6 Patients on Steroid therapy, Inhaler.
7 Patient Suffering from Secondary Respiratory Disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in the sign and symptoms such as Frequency, episodes and intensity of attack, cough with sputum, chest pain, irritation in throat, rhinitis, thirst. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in the levels of chest X ray, AEC, CRP, PFT.
Reduction in scoring pattern of assessment criteria.
|
42 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Asthma is a syndrome of variable airflow obstruction. It is a state of disordered immunity in which the predominant T helper lymphocyte Type -2 immune mechanism drives the production of IgE on exposure to common environment allergens. Globally, asthma is ranked 24th among the leading causes of years lived with disability and 34th among the leading causes of burden of disease, as measured by disability adjusted life years. So a study will be conducted aimed to evaluate the efficacy of Bharangyadi Madhuka in comparison to TalishadiChurna in the management of Tamaka Shwasa for which a total of 60 patients of either sex and age group (25-60 yr) will be selected randomly from OPD & IPD of Kayachikitsa Department and will be divided into two groups each having 30 patients. In group A Bharangyadi Madhuka 6g will be given with vishammatraofmadhusarpi twice after meal and in Group B TalishadiChurna 6g will be given with honey twice after meal for 21 days. Patients will be followed up at a regular interval of 7 days during the course of the trial and 3 post treatment follow ups will be done at regular interval of 7 days. Clinical features and laboratory investigations will be analysed during and after the treatment. Results will be analysed in accordance with the appropriate statistical tests. |