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CTRI Number  CTRI/2021/05/033648 [Registered on: 17/05/2021] Trial Registered Prospectively
Last Modified On: 12/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Bronchial Asthma 
Scientific Title of Study   Evaluation of the effect of Kulattha Guda in Tamak Shwasa (Bronchial Asthma) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arun Kumar Tripathi 
Designation  Professor and Campus Director 
Affiliation  Gurukul campus UAU Haridwar 
Address  OPD 5 P.G. Department of Kaya Chikitsa Gurukul Campus, U.A.U. Haridwar

Hardwar
UTTARANCHAL
249401
India 
Phone  9415720013  
Fax    
Email  draruntripathi@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Kumar Tripathi 
Designation  Professor and Campus Director 
Affiliation  Gurukul campus UAU Haridwar 
Address  OPD 5 P.G. Department of Kaya Chikitsa Gurukul Campus, U.A.U. Haridwar

Hardwar
UTTARANCHAL
249401
India 
Phone  9415720013  
Fax    
Email  draruntripathi@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Arun Kumar Tripathi 
Designation  Professor and Campus Director 
Affiliation  Gurukul campus UAU Haridwar 
Address  OPD 5 P.G. Department of Kaya Chikitsa Gurukul Campus, U.A.U. Haridwar

Hardwar
UTTARANCHAL
249401
India 
Phone  9415720013  
Fax    
Email  draruntripathi@yahoo.com  
 
Source of Monetary or Material Support  
Gurukul Campus UAU Haridwar 
 
Primary Sponsor  
Name  Gurukul Campus UAU Haridwar 
Address  Gurukul Campus UAU Haridwar 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vandana Rawat  Gurukul Campus UAU Haridwar  OPD-5 P.G. Department of Kaya Chikitsa Gurukul Campus UAU Haridwar
Hardwar
UTTARANCHAL 		 9410772565

dr.vannurawat1993@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Gurukul Campus UAU Haridwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J459||Other and unspecified asthma. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kulattha Guda and Virechana  Kulutha Guda- Dose-5 gm BD with lukewarm water-Orally. It will be given for 45 days. Virechana- Virechana will be given with Trivrit Avaleha in dose of 20-30 gm(As requirement per person) orally.  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient having classical features of Tamak Shwasa(Bronchial Asthama) will be selected.
2. Age 18-60 yrs will be included irrespective of sex,religion and caste discrimination. 
 
ExclusionCriteria 
Details  1. Patients below 18 years and above 60 years.
2. Bronchial Asthma associated with complications like emphysema, cor-pulmonale etc.
3. Patients suffering from Pulmonary Tuberculosis, Lung cancer, Lung fibrosis, Acute & chronic Bronchitis.
4. Diabetic patients.
5. Severe attack of asthma.
6. Cardiac disease like cardiac asthma, I.H.D. etc.
7. Patient suffering from other major medical and psychiatric disorders.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Shayane Shwasha piditam (Breathlessness during lying position)
2.Aasinolabhate saukhyam (Comfort in sitting posture)
3.Shleshman aamuchyamane Bhrusham dhukhitam (Difficult to expectorate)
4.Shleshma Vimokshante Muhurtam sukham (Momentary relief after expectoration)
5.Shwasakrichta (Difficulty in breathing)
6.Ghurgurakam (Wheezing sound)
7.Parsve Avagruhyate (Chest tightness)
8.Ativega Kasate (Frequent bouts coughing)
9.Anidra (Disturbed sleep due to breathlessness)
 		 The assessment will be done on the basis of relief in the subjective parameters with the interval of 10 days. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Blood - Hb%, TLC, DLC, ESR.
2.Absolute Eosinophil Count (AEC)
3.X-ray Chest PA view
4.Sputum Examination
5.Pulse oximetery test
6.Peak expiratory flow meter test. 		 At 1st and 45th day.
(Only Pulse oximetery test
and Peak expiratory flow meter test will be done at the interval of 10 days) 
 
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)   22/05/2021 
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   None yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.vannurawat1993@gmail.com].

  6. For how long will this data be available start date provided 21-05-2021 and end date provided 20-05-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study is a open label, randomized, parallel group clinical trial to determine the efficacy of Kulattha Guda in Tamak Shawasa (Bronchial Asthma) for age group between 18-60 years daily for 45 days. The study will be conducted at UAU, Gurukul Campus, Haridwar on 40 patients. The assessment will be done on the basis of Subjective and Objective parameters. The study will be conducted at OPD/IPD level of P.G. Department of Kaya Chikitsa . The assessment will be done at the interval of 10 days of the clinical trial and the results obtained will be tabulated and statistically analyzed using appropriate tests.

 
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