| CTRI Number |
CTRI/2024/04/066421 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Marichadi gutika and sitopaladi vati in management of Shwasa with special
reference to Chronic obstructive pulmonary disease (COPD) |
|
Scientific Title of Study
|
An Open Labelled Active Controlled Randomized Clinical Study to Evaluate the efficacy of Marichadi Gutika in Shwasa with special reference to Chronic Obstructive Pulmonary Disease (COPD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krupa Pravinbhai Patel |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD 116 Department of Kayachikitsa
Parul Ayurved Hospital
Parul University
AP Limda
TAL Waghodia
Vadodara
Gujarat
Vadodara GUJARAT 391760 India |
| Phone |
9712184102 |
| Fax |
|
| Email |
patelkrupa817@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manu R |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD 116 Department of Kayachikitsa
Parul Ayurved Hospital
Parul University
AP Limda
TAL Waghodia
Vadodara
Gujarat
Vadodara GUJARAT 391760 India |
| Phone |
8160858967 |
| Fax |
|
| Email |
manu.r260022@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Manu R |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD 116 Department of Kayachikitsa
Parul Ayurved Hospital
Parul University
AP Limda
TAL Waghodia
Vadodara
Gujarat
Vadodara GUJARAT 391760 India |
| Phone |
8160858967 |
| Fax |
|
| Email |
manu.r260022@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul institute of Ayurveda Parul university
AP Limda
TAL Waghodia
Vadodara
391760
Gujarat
India |
|
|
Primary Sponsor
|
| Name |
Principal Parul Institute of Ayurved |
| Address |
Faculty of Ayurved
Parul University
AP Limda
TAL Waghodia
Vadodara
391760
Gujarat
India
TAL Waghodia
DIST Vadodara
Gujarat |
| Type of Sponsor |
Private medical college |
|
|
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 Krupa Pravinbhai Patel |
Parul Institute of Ayurved |
opd 116 Department of Kayachikitsa
Parul Ayurved Hospital
Parul University
AP Limda
TAL Waghodia
Vadodara
Gujarat Vadodara GUJARAT |
9712184102
patelkrupa817@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul institute of ayurved-inethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J449||Chronic obstructive pulmonary disease, unspecified. Ayurveda Condition: SVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Marichadi gutika, Reference: Sharangdhar samhita madhyama khanda 7/13-15, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sitopaladi vati, Reference: Charaka samhita chikitsa sthana 8/103, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: From 30-year age to 70 years age (inclusive of either age)
2.Gender: Both.
3.Patients diagnosed with Mild to Moderate COPD as per GOLD Guidelines 2023 of Spirometry.
4.Patients willing and able to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant or lactating women.
2.Known case of Diabetes, uncontrolled hypertension, heart disease, secondary severe infections, Pleural effusion, pneumonia and pneumothorax, etc.
3.Severe and very severe cases of copd as per gold guidelines 2023.
4.History of upper or lower respiratory tract infection, within the previous 30 days.
5.History of lung resection of more than one full lobe.
6.Have a known sensitivity to formoterol, ipratropium, and salbutamol etc medicine.
7.Immunocompromised status such as HIV, tuberculosis, cancer, etc.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Effect of Marichadi gutika in Shwasa with special reference to COPD on basis of Spirometry of GOLD guidelines 2023 of COPD. |
Baseline,Day 15,Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare the efficacy of Marichadi gutika with Sitopaladi vati based on PEFR (through Peak flow meter), GOLD Guidelines 2023 of Spirometry for COPD.
Compare the efficacy of Marichadi gutika with Sitopaladi vati on Based on CAT SCORE and Modified MRC dyspnea scale.
Compare the efficacy of Marichadi gutika with Sitopaladi vati Based on Gradation/scoring of the signs and symptoms pattern for Shwasa.
Compare the efficacy of Marichadi gutika with Sitopaladi vati Based on biochemical parameters-AEC and CBC. |
Baseline,Day 15,Day 30 |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
09/05/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic obstructive pulmonary disease (COPD) is a heterogenous lung condition characterized by Chronic respiratory symptoms (dyspnea, cough, sputum production, and exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction caused by exposure to noxious particles or gases, chemical irritants, smoking, tobacco and influenced by host factors including abnormal lung development. It alters the span and quality of life. Excluded from this definition is bronchial asthma, which also produces reversible chronic airflow obstruction. COPD is a group of progressive lung disease, most common are chronic bronchitis and emphysema. it is an inflammatory condition of respiratory system involving the airways, lung parenchyma, and pulmonary vasculature. The process is due to involve oxidative stress and protease-antiprotease imbalances. Chronic bronchitis is characterized by chronic cough with expectoration for at least 3 months of year for > 2 consecutive years. bronchitis causes inflammation and narrowing of bronchial tubes, which allows mucus to build up, cough with expectorated sputum and airflow limitation. Emphysema describes one of the structural changes seen in COPD where there is the slowly progressive destruction of the alveolar air sacs (gas-exchanging surfaces of the lungs) and loss of elastic recoil leading to obstructive physiology with or without fibrosis development. According to Ayurveda, respiratory diseases can be correlated with Pranavaha srotas vikara where cough, breathing difficulties, disturbed respiratory pattern, etc. are the main clinical features. Though it is impossible to correlate COPD with any single disease of Pranavaha sroto dushti, advanced conditions of diseases such as Kasa and Shwasa may result in conditions that resemble COPD. Shwasa roga is chiefly caused by vitiation of vata and kapha dosha but site of origin of this disease is pitta sthana. Vata dosha becomes vitiated in amashaya (pitta sthana samudbhava) due to specific causative factors (nidana). This vata dosha lead to dosha utklesh resulting in Jatharagni mandhya and ultimately there is formation of Ama. due to Jatharagni mandhya also affects Rasadhatu agni mandhya leading to formation of more Rasarupi mala (kapha). This vitiated vata dosha along with vikruta kapha causes the Pranavaha srotas obstruction which leasds to vilomagati of prana vayu contributing to manifestation of shwasa roga. Acharya sushruta explain prana vayu governs the process of breathing, nourishment and performs jatharagni deepana. In shwasa roga prana vayu is hampered by vikruta kapha dosha, it may be reasoning that patient of shwasa roga usually suffers from agni disorder. Many Ayurvedic drugs are effective in managing this disease and Marichadi gutika is one among them. Marichadi gutika is an efficient ayurvedic formulation that can maintain the balance of Vata and Kapha dosha in the body. It is very useful to get rid of respiratory conditions. It is an effective ayurvedic medicine that is helpful in bronchitis, having bronchodilatory effect, improve immunity and reduces inflammation in airway, reduces chest pain, helps in expectorating excess mucus. Ayurvedic research studies have proven that Sitopaladi churna is usefull in treatment of cough, various allergic conditions like bronchial asthma, chronic bronchitis, TB, COPD etc in all ages, stabilizing effects of Sitopaladi Churna on mast cell degranulation is proved. Anti-inflammatory effect, bronchodilation, reduces mucus production in the lungs and mitigates inflammation in the airways and lungs is also proved. This research proposal is aimed to evaluate whether Marichadi gutika will be effective in the management of Shwasa when compared to Sitopaladi vati.l Globally, COPD is major cause of chronic morbidity and mortality throughout the world. 90% of death occur in low- and middle- income countries (lmics). COPD was estimated to be the sixth leading cause of death in 2019. In India, COPD is the second most common lung disorder after pulmonary tuberculosis. Based on BOLD (Burden of obstructive lung disease) and large epidemiological studies, it is estimated that the Global prevalence of COPD is 10.3%. COPD among the population above 30 years in India between the years 2000 to 2020 prevalence of COPD is 7%. The prevalence of COPD is expected to rise over the next 40 years and by 2060 there may be over 5.4 million deaths annually from COPD and related conditions. The prevalence of COPD increased steeply with age, with the highest prevalence among those > 60 years. Prevalence of copd is appreciably higher in smokers and ex-smokers compared to non-smokers, in those> 40 years of age compared to those <40, and in men compared to women. bold reported an overall prevalence of copd of 11.8% for men and 8.5% for women. COPD can be estimated that globally there are around three million deaths annually due to COPD. is also a disease of increasing public health importance around the world. GOLD estimates suggest that COPD will rise from the sixth to the third most common cause of death worldwide by 2023. The increasing prevalence of chronic obstructive pulmonary disease (COPD) has become an issue of serious public health concern. Globally, COPD is major cause of chronic morbidity and mortality throughout the world. 90% of death occur in low- and middle- income countries (lmics). COPD was estimated to be the sixth leading cause of death in 2019. In India, COPD is the second most common lung disorder after pulmonary tuberculosis. Based on BOLD (Burden of obstructive lung disease) and large epidemiological studies, it is estimated that the Global prevalence of COPD is 10.3%. COPD among the population above 30 years in India between the years 2000 to 2020 prevalence of COPD is 7%. The prevalence of COPD is expected to rise over the next 40 years and by 2060 there may be over 5.4 million deaths annually from COPD and related conditions. The prevalence of COPD increased steeply with age, with the highest prevalence among those > 60 years. Prevalence of copd is appreciably higher in smokers and ex-smokers compared to non-smokers, in those> 40 years of age compared to those <40, and in men compared to women. bold reported an overall prevalence of copd of 11.8% for men and 8.5% for women. COPD can be estimated that globally there are around three million deaths annually due to COPD. is also a disease of increasing public health importance around the world. GOLD estimates suggest that COPD will rise from the sixth to the third most common cause of death worldwide by 2023. The increasing prevalence of chronic obstructive pulmonary disease (COPD) has become an issue of serious public health concern. |