| CTRI Number |
CTRI/2020/03/023705 [Registered on: 02/03/2020] Trial Registered Prospectively |
| Last Modified On: |
02/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic treatment of breathlessness and cough. |
|
Scientific Title of Study
|
A Single Arm Clinical Study To Evaluate The Efficacy Of Madhuyastikalp (Titrated Dose)And Rasayan Chikitsa In The Management Of Bronchiectasis Vis-A-Vis Kshataksheena |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mithlesh Meena |
| Designation |
P.G.Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department of Kayachikitsa 6th Floor, Academic Block
All India Institute of Ayurveda
Gautampuri, Sarita Vihar, Mathura Road, New Delhi
South
DELHI
110076
India |
| Phone |
7974915048 |
| Fax |
|
| Email |
mithleshmeena2606@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Kajaria |
| Designation |
Assistant professor |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department of Kayachikitsa 6th Floor, Academic Block
All India Institute of Ayurveda
Gautampuri, Sarita Vihar, Mathura Road, New Delhi
South
DELHI
110076
India |
| Phone |
8826167515 |
| Fax |
|
| Email |
divyakajaria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mithlesh Meena |
| Designation |
P.G.Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Department of Kayachikitsa 6th Floor, Academic Block
All India Institute of Ayurveda
Gautampuri, Sarita Vihar, Mathura Road, New Delhi
South
DELHI
110076
India |
| Phone |
7974915048 |
| Fax |
|
| Email |
mithleshmeena2606@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda
Gautampuri,Sarita Vihar,Mathura Road,New Delhi 110076 |
|
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Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, gautampuri,Sarita Vihar,Mathura Road, New Delhi 110076 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrMithlesh Meena |
All India Institute Of Ayurveda |
Room no-001, Unit Kayachikitsa, hospital block AIIA
Gautampuri Sarita vihar Mathura road New Delhi 110076
South
DELHI |
7974915048
mithleshmeena2606@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Madhuyasti churna.
Jivantyadi ghrita with prakshep of trikatu churna,anupana of triphala kwath and tankan bhasma. |
madhuyasti churna- 6gm churna given empty stomach with milk
Everyday successive increase of madhuyasti churna till it reaches 48gm and from that the dose tapered by 6gm for 15 days.
2.Then followed by Jivantyadi ghrita 20ml once in a day for one month.
prakshep dravya- 3gm trikatu churna.
Anupana- 50ml triphala kwath and 125mg tankan bhasm. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having classical sign and symptoms of Kshataksheen
2.The study will include individuals with known diagnosis of Bronchiectasis by high resolution computed tomography (HRCT) scan
3.Clinically being stable minimum from one month
4.Not under going excercise training programme or nay other lung rehabilitation therapy
5.No acute exacerbation of Bronchiectasis |
|
| ExclusionCriteria |
| Details |
1.Severe obstructive airway disease (FEV1 <50%, FEV1/FVC<70%)
2.Patients who are unable or unwilling to provide informed consent
3.Diagnosis of other active lung diseases (i.e. ABPA, active tuberculosis)
4.Patient taking steroid therapy from long duration (systemic or inhaled)
5.Past or current malignancy within 5 years
6.Pregnant ladies and lactating mothers
7.History of any adverse drug reaction
8.Patients having positive HIV1 and 2 or positive Hepatitis B
9.Patients with severe cardiovascular disease
10.Patients with poorly controlled Hypertension (>160/100mmhg)
11.Patients with cystic fibrosis or history of cystic fibrosis
12.Patients having Diabetes Mellitus |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in sign and symptoms of Bronchiectesis (Kshataksheen) |
105 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Chnages in MRC dyspnoea scale
2.Changes in HRCT scan
3.Change in PFT
4.Bronchiectasis health questionnaire
5.Change in quality of life |
105 days |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/03/2020 |
| 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="21"
Months="1"
Days="1" |
|
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)?
|
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Brief Summary
|
Bronchiectasis is characterised by permanent and abnormal dilatation of the lung airways (bronchi). It arises from persistent bacterial airway infection on a background of a deficient immune response .the classical presenting complaints in patients of post tubercular bronchiectasis are cough with copious sputum –mucoid, mucopurulent or purulent. dyspnea, haemoptysis is, chest pain and fever may be present in varying proportions. Bronchiectasis is seen in 30–60% of patients with active postprimary form TB and in 71–86% of patients with inactive disease. In Ayurveda, signs and symptoms of Urakshata are very similar to bronchiectasis of modern medicine. The cardinal features are (cough) kasa with yellowish-black, foul smelling sputum and (haemoptysis) shonitachhardi. Ayurveda also considers interrelation-ship between bronchiactasis (Urakshata) and tuberculosis (Rajyakshma). According to Charaka, Urakshta if not treated appropriately, may further lead to Rajyakshma. In Ayurveda jivantyadi ghrita has good efficacy in reducing productive cough, haemoptysis, dyspnea and thus it is in bronchiectasis.
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