| CTRI Number |
CTRI/2023/06/054060 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
15/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Dashmoolaadi kwatha in bronchial asthma(tamak shwasa) |
|
Scientific Title of Study
|
Clinical evaluation of dashmoolaadi kwatha with & without virechana in tamak shwasa |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Someen Pant |
| Designation |
Pg scholar |
| Affiliation |
Uttarakhand Ayurveda University, Gurukul campus, Haridwar |
| Address |
OPD 5 PG department of kayachikitsa, Uttarakhand Ayurveda University,Gurukul campus, Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
8755245692 |
| Fax |
|
| Email |
pant.drsomeen02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Kumar Goyal |
| Designation |
Professor |
| Affiliation |
Uttarakhand Ayurveda University ,Gurukul campus, Haridwar |
| Address |
OPD 5 PG Department of kayachikitsa, Uttarakhand Ayurveda University, Gurukul Campus, haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9411731180 |
| Fax |
|
| Email |
dineshdr157@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Someen Pant |
| Designation |
Pg scholar |
| Affiliation |
Uttarakhand Ayurveda University |
| Address |
OPD 5 PG department of kayachikitsa, Uttarakhand Ayurveda University,Gurukul campus, Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
8755245692 |
| Fax |
|
| Email |
pant.drsomeen02@gmail.com |
|
|
Source of Monetary or Material Support
|
| UAU Gurukul Campus, haridwar |
|
|
Primary Sponsor
|
| Name |
Someen pant |
| Address |
OPD 05 PG department of kayachikitsa, Uttarakhand Ayurveda University,Gurukul campus, haridwar |
| 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 |
| Someen pant |
UAU,Gurukul campus, haridwar |
OPD 5 PG Department of kayachikitsa, UAU,Gurukul campus, haridwar
Hardwar
UTTARANCHAL |
8755245692
pant.drsomeen02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC UAU Gurukul Campus |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashmooladi kwatha, Reference: charaka chikitsa 17/ 102-103, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: dashmooladi kwatha after virechana , Reference: charaka chikitsa 17/ 102-103, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having classical features of Tamak Shwasa as mentioned in classics.
Male or female between the age group 18-60 years.
Patient fit for Virechana.
|
|
| ExclusionCriteria |
| Details |
Patients below 18 years and above 60 years.
Bronchial asthma associated with complications like emphysema,cor-pulmonale etc.
Patient suffering from Pulmonary tuberculosis, Lung cancer, Lung fibrosis,Bronchitis
Severe attack of asthma
Cardiac disease like cardiac asthma, IHD etc.
Patient suffering from other major medical and psychiatric disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shayanah shwasa pidatah (Breathlessness during lying position)
Aasinolabhate saukhyam (comfort in sitting posture)
Shleshmanayamuchyamane tu bhrisham bhavati dukhitah (difficult to expectorate)
shleshma Vimokshante Muhurtam labhate sukham (momentary releif after expectoration)
Shwasakrichta (difficulty in breathing)
Ghurgurukam (wheezing sound)
Parsve Avagruhyate (chest tightness)
Ativega kasate (frequent bouts coughing)
|
At 1st, 15th & 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Peak expiratory flow rate
Oxygen saturation
Absolute Eosinophil Count(AEC)
ESR |
At 1st 15th 45th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/07/2023 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a open label,randomized,parallel group clinical trial to determine the efficacy of dashmoolaadi kwatha with and without virechana in tamak shwasa (Bronchial Asthma) for the age group between 18-60 years for 45 days.Study will be conducted at UAU, Gurukul Campus, Haridwar on 40 patients. Assessment will be done on the basis of subjective and objective parameters. Study will be conducted at OPD/IPD level of PG department of Kayachikitsa. Assessment will be done at the interval of 15 days of clinical trial and result obtained will be tabulated and statistically analyzed using appropriate tests |