| CTRI Number |
CTRI/2018/02/011918 [Registered on: 15/02/2018] Trial Registered Prospectively |
| Last Modified On: |
15/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ayurvedic treatment in COPD |
|
Scientific Title of Study
|
A Comparative study to Evaluate Efficacy of "Shwasa Kuthar Rasa" and "Pippali Vardhman Rasayan" in the management of Chronic Obstructive Pulmonary Disease(Praanavaha Sroto Dushti) |
| Trial Acronym |
COPD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogesh Kumar Pandey |
| Designation |
Associate Professor |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh, New Delhi |
| Address |
Department of Kayachikitsa,
Ch. Brahm Prakash Ayurved Charak Sansthan,
Khera Dabar Najafgarh,
New Delhi
New Delhi
DELHI
110073
India |
| Phone |
9013858523 |
| Fax |
|
| Email |
dryogeshpandey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Kumar Pandey |
| Designation |
Associate Professor |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh, New Delhi |
| Address |
Department of Kayachikitsa,
Ch. Brahm Prakash Ayurved Charak Sansthan,
Khera Dabar Najafgarh,
New Delhi
New Delhi
DELHI
110073
India |
| Phone |
9013858523 |
| Fax |
|
| Email |
dryogeshpandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Garg |
| Designation |
PG Scholar |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh, New Delhi |
| Address |
Department of Kayachikitsa,
Ch. Brahm Prakash Ayurved Charak Sansthan,
Khera Dabar Najafgarh,
New Delhi
New Delhi
DELHI
110073
India |
| Phone |
9013858523 |
| Fax |
|
| Email |
neha9garg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch.Brahm Prakash Ayurved Charak Sansthan Khera DabarNajafgarh New Delhi 110073 |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar Najafgarh New Delhi |
| Type of Sponsor |
Other [State Government Ayurvedic College] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Kayachikitsa |
Ch Brahm Prakash Ayurved Charak Sansthan,
Khera Dabar Najafgarh New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yogesh Kumar Pandey |
Ch Brahm Prakash Ayurved Charak Sansthan Hospital, Khera Dabar Najafgarh New Delhi |
Kayachikitsa OPD
New Delhi
DELHI |
9013858523
dryogeshpandey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ch. Brahm Prakash Ayurved Charak Sansthan,NCT Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients of COPD, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pippali Vardhman Rasayan |
Starting from 6 pippali from first day each day 6 pippali will be added till the 13th day . From 14th day 6 pippali will be consumed in a study of 25 days orally |
| Comparator Agent |
Shwasa Kuthar Rasa |
125 mg tablets(2 TDS) with Pan Patra orally for 25 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age Group between 35-65 years.
2. Patients of Both Sexes.
3. Smoking history current or former active ciggarette smokers or history of occupational exposure to COPD.
4.Patients present with signs and symptoms of COPD.
5.Radiographic evidence suggestive of COPD.
6.Spiro-metric diagnosis of COPD(as per GOLD criteria)
7. The patients who are ready to sign informed consent form to participate in study.
8. The patients who are ready to be consistent in visits during whole trial period.
9. Firm home address and contact number which is readily accessible during whole course of trial.
|
|
| ExclusionCriteria |
| Details |
1) Seriously ill and morbid patients which are unlikely to survive for next 6 months.
2) Pregnant and lactating women
3) Patient with alcohol dependence
4) History of hypersensitivity to any of trial drug
5) Patient with serious hepatic disorder, renal disorder, diabetes mellitus or any condition that may jeopardize the study
6) Patient with any other concomitant respiratory disorder
7) Patient with co-morbid disorders(Diabetes Mellitus, Pulmonary Tuberculosis ,Rheumatoid Arthritis , Carcinoma)
8) Patient with poorly controlled hypertension (systolic >160 mmHg and diastolic > 100 mmHg)
9) Patient receiving mast cell stabilizers, anti-depressants, anticholinergics etc. or any other drugs that may have an influence on the outcome of the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Improvement in BODE index(Body mass index, Obstruction, Dyspnoea, Exercise endurance) score
2) Improvement in SGRQ(St. George’s Respiratory Questionnaire) score
3) Improvement in severity of clinical symptoms of Praanavaha Sroto Dushti.
|
Every 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Improvement in Forced Expiratory Volume in 1 second (FEV1) pre and post bronchodilator intake.
2) Improvement in FEV1/FVC ratio pre and post bronchodilator intake
3) Reduction in episodes of cough
4) Reduction in volume of sputum produced
5) Percentage of patients who acquired lakshanas of karyaphala described in Charaksamhita.
|
Every 7 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 3 |
|
Date of First Enrollment (India)
|
01/03/2018 |
| 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 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)?
|
|
Brief Summary
|
COPD is a disease state characterised by progressive development of chronic airflow limitation caused by chronic inflammation of airways and lung parenchyma .It leads to gradual decline in the lung function and worsening of dyspnoea and health status .
Ciggarette smoking and occupational smoke produces free radicals which in turn irritates mucus glands causing over secretions of mucus. This causes irritation of airways leading to inflammation which ultimately lead to obstruction in airflow due to narrowing of pathways. Thus the poor Thoraco-Abdominal respiration due to COPD needs a safe , cost effective , easy to administer, evidence based treatment which not only combat with the signs and symptoms of the disease but also uproot the basic pathology which has occured in due course of time without any adverse effects.
In modern sciences treatment of COPD includes Bronchodialators, Corticosteroids, Antibiotics and Oxygen Supplimentation.But in this trial comparative study of Shwasa Kuthar Rasa and Pippali Vardhman Rasayan has been selected(Ayurvedic Medicines).
If Pippali Vardhman Rasayan proves effective and safe in treatment of COPD it would enable us to formulate a new treatment regimen which would not only be of shorter duration but also be economical and affordable to the economically deprived masses around the globe. It will also allay the fears of the side effects of treatment regimen followed in COPD.It may also prove helpful to great extent in the prevention of extensive drug resistance and multi drug resistance . It may also be used as cost effective, easily available and quite affordable alternative treatment for the patients suffering from COPD.
|