| CTRI Number |
CTRI/2024/07/071114 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Nigdigdhikadi Kwatha And Ghritayavadi Dhuma In The Management Of COPD. |
|
Scientific Title of Study
|
Efficacy of Nidigdhikadi Kwatha alone & in combination with Ghritayavadi Dhuma in the management of Tamaka shwasa
w. s.r to Grade -I COPD, A double arm open -label comparative study. |
| 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 Abinash Kar |
| Designation |
MD Scholar Department Of Kayachikitsa |
| Affiliation |
Ayurvedic And Unani Tibbia College And Hospital |
| Address |
Pg Department Of Kaya Chikitsa
Ayurvedic And Unani Tibbia College And Hospital
Ajmal Khan Road
Karolbagh
Pg Department Of Kaya Chikitsa
Ayurvedic And Unani Tibbia College And Hospital
Ajmal Khan Road
Karolbagh
Central DELHI 110005 India |
| Phone |
7978726724 |
| Fax |
|
| Email |
drabinash1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR SUJATA YADAV |
| Designation |
ASSOCIATE PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
AYURVEDIC AND UNANI TIBBIA COLLEGE AND HOSPITAL |
| Address |
ROOM NO-6
PG DEPARTMENT OF KAYACHIKITSA
AYURVEDIC AND UNANI TIBBIA COLLEGE AND HOSPITAL
KAROLBAGH
Central DELHI 110005 India |
| Phone |
9810571653 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sujata Yadav |
| Designation |
Associate Professor And Head of The Department |
| Affiliation |
Ayurvedic And Unani Tibbia College And Hospital |
| Address |
Pg Department Of Kaya Chikitsa
Ayurvedic And Unani Tibbia College And Hospital
Ajmal Khan Road
Karolbagh
Central DELHI 110005 India |
| Phone |
9810571653 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic And Unani Tibbia College And Hospital |
|
|
Primary Sponsor
|
| Name |
Ayurvedic And Unani Tibbia College And Hospital |
| Address |
Ayurvedic And Unani Tibbia College And Hospital
Karolbagh
110005 |
| Type of Sponsor |
Government 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 Abinash Kar |
Ayurvedic And Unani Tibbia College And Hospital |
Ajmal Kahan Road
Karolbagh
New Delhi
110005 Central DELHI |
7978726724
abinashkar1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurvedic And Unani Tibbia College And Hospital |
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: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nidigdhikadi kwath, Reference: sarangdhar madhyama khanda kwath prakaran, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -pippali churna 1gm), Additional Information: GHRITAYAVADI DHUMA
REF-SUSHRUTA UTTARATANTRA 51/52
Dosage- 3 puffs through mouth twice a day for 7 days duration [every 15 days] | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NIDIGDHIKADI KWATHA, Reference: SARANGADHAR MADHYAMA KHANDA KWATHA PRAKARANA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: PIPPALI CHURNA 1 GM), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Symptomatological criteria - patients having history of respiratory signs and symptoms mentioned in modern texts such as chronic cough, increased sputum production, exertional dyspnea, wheezing, chest tightness, Recurrent lower
respiratory tract infections with a history of exposure to risk factors (Host factors–
Genetic factors, Tobacco smoke, Occupation, Indoor or outdoor pollution)
2 Spirometry criteria–FEV1 divided by FVC less than 0.7and FEV1 greater than equals to 80 percent
3 Patients willing to participate in trial |
|
| ExclusionCriteria |
| Details |
1 Pregnant and lactating women Patients having respiratory complications like Cor-pulmonale, and diseases like Active Pulmonary TB, Pneumonia, Status Asthmaticus, Cystic fibrosis, Pleural
effusion, Pneumothorax, Lung cancer and other systemic diseases like Severe
anaemia, Renal failure, Cardiovascular disease.
2 Patients suffering from malignant and accelerated hypertension( 160 by 100 mm of
Hg), coronary artery disease, uncontrolled diabetes(HbA1c greater than 8 percent).
3 Patient undergoing regular treatment for any other severe illness and also patient
on prolonged corticosteroid use. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective parameters like mMRC (Modified British Medical Research Council) Dyspnea scale , CAT (COPD assessment test) scale , GOLD criteria of spirometry , BODE index for Quality of life.
|
Day1,Day 91 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall improvement in quality of life. |
Day1,Day 91 |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
INTRODUCTION: Respiration is the most important feature of life which is carried out by Rana Vayu.iThere are various diseases like Hikka , Shwasa , Kasa in which Prana Vayu get vitiated. Tamaka Shwasa is one among them. In Ayurveda Tamaka Shwasa is categorized under the five types of Shwasa which affects Prana Vaha Srotas. Main causative factors responsible for Tamaka Shwasa are Raja , Dhuma , Shitasthana- Shitambu Sevana etc , which leads to vitiation of Vata with Kapha leading to vitiation of function of Prana Vaha Srotas. Acharya Charaka has mentioned that Tamaka Shwasa is Kapha-Vataja Vikaraand site of its origin is Pitta Sthana. As per Acharya Charaka , Tamaka Showers is considered as Yapyavyadhi. However in individual with recent origin of disease and Pravara Bala person , it is said to be Sadhya. Chronic obstructive pulmonary disease on the basis of its etiological factors , signs and symptoms & pathophysiology can be correlated with advanced stage of Tamara Shwasa. Chronic Obstructive Pulmonary Disease (COPD) is a common , preventable & treatable disease that is characterised by persistent respiratory symptoms and airflow limitation that is not fully reversible .iiThe most common respiratory symptoms include dyspnea , cough and/or sputum production. COPD includes chronic bronchitis (cough & expectoration for 3 months in 2 consecutive years) , emphysema (abnormal permanent enlargement of airspaces distal to terminal bronchioles) and small airway disease (small bronchioles are narrowed and reduced in number).iii NEED AND SIGNIFICANCE:
Now a days majority of diseases affecting people are due to new age lifestyle , habits , occupational and environmental factors .Smoking and atmospheric pollution causes more incidence of disease .Today there is increased growth of industry which pollutes environment and also affects the people working in those industries and leads to various respiratory diseases and COPD is one among them. Recently cases of COPD are increasing day by day due to poor education of disease , low socio-economic status , lack of healthy lifestyle and poor hygiene , especially in India. In modern medicine for management of COPD , bronchodilators (oral/inhaler , long/short acting) , anti-inflammatory agents , antibiotics, antimuscarinic agents, mucolytic agents , methyl xanthines are commonly used and for severe conditions inhaled corticosteroids , oxygen therapy and surgery is also needed. But till date there is no any clinical evidence that any of these medications for COPD modify the long-term decline in lung function and quality of life and these are only effective in reducing symptoms , severity and frequency of exacerbations. Ayurveda has a significant role in management of diseases of Prana Vaha Srotas (COPD). In Ayurveda , line of treatment of every diseases is Nidana Parivarjana that includes avoidance of causative factors of disease , modification of life style and diet. So , as per Ayurveda , treatment of COPD includes Nidana Parivarjana , Shodhana (purification of Doshas) , Shamana and Rasayana Chikitsa , which can contribute effectively in management of COPD. DIAGNOSTIC CRITERIA:
Standard criteria for diagnosis of Chronic Obstructive Pulmonary Disease mentioned by Global initiative for Chronic Obstructive Lung Disease in Global strategy for the diagnosis , management , and prevention ofChronic Obstructive PulmonaryDisease (2021 Report )xxvwill be followed. 1. The most common respiratory symptoms such as Chronic cough (May be intermittent and may be unproductive) , Chronic sputum production , and Exertional dyspnea ( Persistent , progressive over time , and worsen with exercise ) , wheezing and Chest tightness which may vary from day-to-day and precede the development of airflow limitation by many years. 2. Variable expiratory air flow limitation done by Spirometry. LABORATORY INVESTIGATION: 1.CBC -before & after treatment 2.ESR -before & after treatment 3.AEC -before & after treatment 4.LFT -before & after treatment 5.KFT -before & after treatment 6.HbA1C -before & after treatment 7.LIPID profile -before & after treatment 8.ECG -before treatment. 9.Chest X - ray PA view -before treatment 10.SPIROMETRY -every 30 days 11 .PULSE OXYMETRY - every visit 12. Urine Routine & microscopic - before treatment only to rule out any Urological & nephrological Pathology
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