| CTRI Number |
CTRI/2024/11/077347 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| 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
|
To Study The Effectiveness Between Drakshadi Churna And Vasa Avaleha In Tamak Shwas (Asthma) |
|
Scientific Title of Study
|
A randomised controlled clinical trial to evaluate the efficacy of Drakshadi Churna in management of Tamak Shwas Avegawastha in children with age group of 6 to 12 years. |
| 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 Aniket Arjun Bhosale |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Ayurved and Research Centre Nigdi Pune |
| Address |
PDEAS College of Ayurveda and Research Centre Balrog
department third floor Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7057453977 |
| Fax |
|
| Email |
bhosaleaniket191@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Deodas |
| Designation |
Professor and HOD |
| Affiliation |
PDEAS college of Ayurveda and Research centre Nigdi |
| Address |
PDEAS College of Ayurveda and Research Centre Balrog
department third floor Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Deodas |
| Designation |
Professor and HOD |
| Affiliation |
PDEAS college of Ayurveda and Research centre Nigdi |
| Address |
PDEAS College of Ayurveda and Research Centre Balrog
department third floor Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College of Ayurved and Research Centre sector 25
pradhikaran nigdi Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAS college of Ayurved And Research centre Nigdi pune |
| Address |
PDEAS College of Ayurveda and Research Centre Sector 25
Pradhikaran Nigdi Pune Maharashtra |
| 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 Aniket Arjun Bhosale |
Ayurved Rugnalaya and Sterling Multispeciality Hospital Nigdi Pradhikaran Pune |
Ayurved Rugnalay And
Sterling Multispeciality
Hospital Nigdi
Pradhikaran Pune
Sector 27 Balrog
Department OPD No
118
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7057453977
bhosaleaniket191@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson 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: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Drakshadi Churna, Reference: Brihat Nighantu Ratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 750(mg), Frequency: tds, Bhaishajya Kal: Madhyabhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Sarpi and Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vasa Avaleha, Reference: -, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 700(mg), Frequency: tds, Bhaishajya Kal: Madhyabhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Lukewarm water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Classical signs and symptoms of Tamak Shwas like Shrama Shwas Dyspnoea on exertion Ghurghurak Pinasa Kaas etc
Known case of Bronchial asthma
Patients in age group of 6 to 12 years irrespective of gender |
|
| ExclusionCriteria |
| Details |
Status asthamaticus
Known case of COPD Pleural effusion Tuberculosis Congenital anamolies Metabolic disorders |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study The Efficacy Of Drakshadi Churna For 7 Days In The Management Of Tamak Shwas Avegawastha |
15 Days Study Follow Up On 3rd,5th,7th,15th day.
Efficacy assessed based on symptoms reduced in how many days as compared to controlled
group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effect if any |
15 days where follow up on 3rd, 5th, 7th, 15th day. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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 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
|
Tamak shwas is Vaat-Kapha dominant disease of Pranvaha srotas and is Aamashaya samudhbhav disease. The word Tamaka Shwasa means a state in which a sense of darkness prevails due to Movement of Prana Vayu in wrong direction. In Allopathy Tamak shwas is corelated with Bronchial Asthma which is chronic disease of respiratory system causing inflammation and obstruction of airways. In this disease chronic inflammation leads to recurrent episodes of asthamatic exacerbations and shows symptoms like shortness of breath, cough, wheezing and chest discomfort. Keeping in view on present scenario of highest prevalence of childhood asthma the disease has been selected for the study. |