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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J449||Chronic obstructive pulmonary disease, unspecified. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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]
2Intervention ArmDrugClassical(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 SrotasAcharya 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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