| CTRI Number |
CTRI/2020/09/027722 [Registered on: 10/09/2020] Trial Registered Prospectively |
| Last Modified On: |
08/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study of Shatyadi Churna And Vasadi Kashaya With And Without Nitya Virechana In The Management Of Tamak Shwasa W.S.R. COPD |
|
Scientific Title of Study
|
"Randomized Comparative Clinical Evaluation Of Shatyadi Churna and Vasadi Kashaya with and without Nitya Virechana in the management of Tamaka Shwasa w.s.r to Chronic Obstructive Pulmonary Disease" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikash Kumar Vikrant |
| Designation |
M.D.(Ayu.) Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Dept. of Kayachikitsa
National Institute of Ayurveda
Jaipur, India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9340330486 |
| Fax |
|
| Email |
drvk1980@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Upadhyay |
| Designation |
Lecturer |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Dept. of Kayachikitsa
National Institute of Ayurveda
Jaipur, India
P.G. Dept. of KayachikitsaNational Institute of AyurvedaJaipur, India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9915613039 |
| Fax |
|
| Email |
dr.abhishek82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikash Kumar Vikrant |
| Designation |
M.D.(Ayu.) Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Dept. of Kayachikitsa
National Institute of Ayurveda
Jaipur, India
RAJASTHAN
302002
India |
| Phone |
9340330486 |
| Fax |
|
| Email |
drvk1980@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur, Rajasthan
302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jaipur, India
302002 |
| Type of Sponsor |
Government medical college |
|
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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 Vikas Vikrant |
NIA Hospital |
OPD No. 1, 7, 18, 25
Department of Kayachikitsa
National Institute of Ayurveda
Jaipur, Rajasthan
302002
Jaipur
RAJASTHAN |
9340330486
drvk1980@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIA IEC |
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: J449||Chronic obstructive pulmonary disease, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Shatyadi churna , Vashadi kashaya and Shodhana Ghrita |
Group A :In the trial group A, 20 patients of Tamaka Shwasa roga i.e. COPD will be administered Shatyadi churna (dose 5gm) and Vashadi Kashaya (dose 40 ml) twice a day orally empty stomach for 30days. And Group B Administered Shatyadi churna (dose 5gm), Vasadi Kashaya (Dose40ml) twice a day orally empty stomach for 30 days and Shodhan Ghrita (Dose 15ml ) will be administered for Nitya virechan at bed time for 30 days. |
| Intervention |
Shatyadi churna and Vashadi kashaya with Shodhana Ghrita |
Group B: i. In the trial group B, 20 patients of Tamaka Shwasa roga i.e. COPD will be administered 5gm Shatyadi churna and 40 ml Vashadi kashaya twice a day orally empty stomach for 30 days. ii. Patients in this group will be administered Nitya virechana with 15 ml Shodhana ghrita at bed time for 30 days. |
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects willing to participate in this clinical trial.
2. Patients in the age group of 30 to 70 years of either sex.
3. Patients who have FEV1/FVC <0.7 on post bronchodilator spirometry. |
|
| ExclusionCriteria |
| Details |
1. Age below 30 and above 70years of age. 2. Patients suffering from Pulmonary Tuberculosis, Pleural effusion. 3. Patients suffering from Bronchiectasis. 4. Patient suffering from Bronchial Asthma. 5. Patients suffering from congestive heart failure. 6. Patients suffering from Bronchogenic carcinoma or other form of malignancies. 7. Status asthmaticus. 8. Patients with Haemoglobin less than 9 mg/dl. 9. Pregnant and lactating women. 10. Patients suffering from serious systemic disorders like Renal diseases, Ischemic heart Disease, Malignant Hypertension, uncontrolled Diabetes Mellitus. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the sign & symptoms of Tamak Shwasa w.s.r. to COPD |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the pulmonary function test i.e. improvement in the PFT parameters |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
NEED OF STUDY: - Ayurveda has advocated Kapha-vata shamak and Vatanulomana chikitsa as line of treatment of Shwasa roga. - Shatyadi churna and Vasadi Kashaya have been selected for the present research work as both the trial drugs are Kapha-vata shamaka in nature and have potential to break or reverse the Samprapti of Shwasa roga. - Acharya Charaka has also indicated the Virechana in the treatment of Tamaka Shwasa. Hence it is planned to see whether addition of Virechana produces any significant difference in the treatment outcome. For the same Snighdha Nitya virechana is selected keeping in view the Alpabala and Pratiloma gati of Vata in the patients of Tamak Shwasa Roga w.s.r. to COPD.
Aims and Objectives 1. To assess the efficacy of Shatyadi Churna andVasadi Kashaya in the management of Tamaka Shwasa w.s.r.to COPD. 2. To assess whether administration of Nitya virechana causes any difference in the outcome of trial drug.
Research Problem: i. Are Shatyadi churna and Vasadi kashaya effective in the management of Tamak Shwasa roga w.s.r. to COPD? ii. Does Nitya virechana enhance the efficacy of the trial drugs?
HYPOTHESIS: Null Hypothesis: i. Shatyadi churna and Vasadi kashaya are not effective in the management of Shwasa roga w s.r. to COPD? ii. Nitya virechana does not enhance the efficacy of the trial drugs.
Alternate hypothesis: i. Shatyadi kand Vasadi kashaya are effective in the management of Tamak Shwas roga w.s.r. to COPD? ii. Nitya virechana enhance the efficacy of the trial drugs.
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