| CTRI Number |
CTRI/2024/10/075754 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the effects of haridra dhupan in shawasa |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY OF EFFICACY OF HARIDRA DHUPAN IN THAMAK SHWASA VEGAWASTHA 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 Pushpa |
| Designation |
PG scholar Kayachikitsa |
| Affiliation |
Government Ayurvedic College , Nanded Maharashtra |
| Address |
Government Ayurveda college, Nanded
Opd no 18 Department of Kayachikitsa government Ayurvedic college vazirabad Nanded
Maharashtra
Pin code - 431601
Maharashtra
431601
India
Nanded
MAHARASHTRA
431601
India |
| Phone |
8295686601 |
| Fax |
|
| Email |
pushpasheokand2310@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parshuram Dongare |
| Designation |
HOD and professor Kayachikitsa |
| Affiliation |
Government Ayurvedic College , Nanded Maharashtra |
| Address |
Department of Kayachikitsa government Ayurvedic college vazirabad Nanded Maharashtra 431601
Nanded
Maharashtra
431601
India
Nanded
MAHARASHTRA
431601
India |
| Phone |
8295686601 |
| Fax |
|
| Email |
dongarepd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parshuram Dongare |
| Designation |
HOD and Professor Kayachikitsa |
| Affiliation |
Government Ayurvedic College , Nanded |
| Address |
Department of Kayachikitsa government Ayurvedic college vazirabad Nanded Maharashtra 431601
Nanded
Maharashtra
431601
India
MAHARASHTRA
431601
India |
| Phone |
8295686601 |
| Fax |
|
| Email |
dongarepd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic college vazirabad nanded
Pincode 431601
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Dr Pushpa |
| Address |
Opd no 18 department of Kayachikitsa government Ayurvedic college vazirabad nanded 431601 nanded Maharashtra india |
| 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 Pushpa |
Government Ayurvedic college and hospital nanded |
Opd no 18 department of Kayachikitsa government Ayurvedic college vazirabad nanded
Nanded
Maharashtra
Nanded
MAHARASHTRA |
8295686601
pushpasheokand2310@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee government Ayurvedic college and hospital nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, (2) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Drug Allopathic |
Medicine named salbutamol route of administration is inhalation with a dose of as prescribed by physician frequency of drug is SOS given for duration of 5-10 minutes |
| Intervention |
Drug classical |
Medicine named haridra reference bhavprakash nighantu route of administration is inhalation with a dose of 10g is given and frequency SOS bhasjya kal SOS and for duration of 5-10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with tamak shawas vegawastha/Bronchial Asthma |
|
| ExclusionCriteria |
| Details |
Patients having acute exacerbation of asthma at the time of registration
Patients having severe persistent asthma as per GINA classification
Patients having tuberculosis pneumonia bronchiectasis and SPO2 5 80%
Patient having history of any hypersensitivity to any of the ingredient/s of the trial drugs
Patients having history of malignancy Hematemesis,on immunotherapy and having any other concomitant systemic illness which required immediate medical intervention
Patients receiving Steroid/ Broncho dilator (orally/inhaled) in last 6 hours
Pregnant and lactating mothers
Patients having bronchial asthma more than 5 years |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the effect of Haridra Dhupan in improving lung function such as
PEFR FEV1 FVC
To determine the effect of Haridra Dhupan in improving asthma symptoms and
reducing the severity of tamak swasa vegawastha |
5-7 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effect of Haridra Dhupan on nasal symptoms score
To determine the safety of Haridra Dhupan in patients of Tamak Shwasa
To determine the effect of Haridra Dhupan in Improving SPO2 oxygen saturation |
5-7 minutes |
|
|
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)
|
05/11/2024 |
| 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="2"
Months="0"
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
|
Ayurvedic literature has vast references of formulations indicated for clinical conditions similar to asthma. Particularly on haridra, previously very few research work was done in tamak shwas-vegawastha Thus, the present clinical study has been planned so as to establish an effective management of the same through the use of dhupan i.e. external procedure which is more safer, easily available at home, easily administrable and cost effective for the patient. So, for that purpose, we have chosen Haridra Dhupan. Haridra (Curcuma longa) can be regarded as drug for management of many diseases its mean phytocomponent is curcumin which displayed various pharmacological activities including anti-inflammatory, anti bacterial, immunostimulant, cardiovascular protective but, no such research work was done on action haridra in tamak shwasa vegawastha as dhupan dravya.
|