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CTRI Number  CTRI/2021/07/035137 [Registered on: 26/07/2021] Trial Registered Prospectively
Last Modified On: 05/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Other 
Public Title of Study   ASSESSMENT OF THERAPEUTIC EFFICACY OF SIDDHA FORMULARY DRUG SWASAKASA NEI IN THE MANAGEMENT OF SWASAKASAM (BRONCHIAL ASTHMA) 
Scientific Title of Study   AN OPEN CLINICAL TRIAL OF SIDDHA FORMULARY DRUG SWASAKASA NEI IN THE MANAGEMENT OF SWASAKASAM (BRONCHIAL ASTHMA) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr A SIVA 
Designation  PG SCHOLAR 
Affiliation  National Institute of Siddha 
Address  Room No 1 Department of Maruthuvam National Institute of Siddha Tambaram sanatorium chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9884662442  
Fax  22381314  
Email  drashwinshiva.a@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr H VETHA MERLIN KUMARI 
Designation  ASSOCIATE PROFESSOR 
Affiliation  National Institute of Siddha 
Address  Room No 1 Department of Maruthuvam National Institute of Siddha Tambaram sanatorium chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9894782366  
Fax  22381314  
Email  dr.vetha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr A SIVA 
Designation  PG SCHOLAR 
Affiliation  National Institute of Siddha 
Address  Room No 1 Department of Maruthuvam National Institute of Siddha Tambaram sanatorium chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9884662442  
Fax  22381314  
Email  drashwinshiva.a@gmail.com  
 
Source of Monetary or Material Support  
Ayothidoss pandithar hospital, National Institute of Siddha,Tambaram sanatorium, Chennai-600047. 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Ayothidoss pandithar hospital, National Institute of Siddha,Tambaram sanatorium, Chennai-600047. 
Type of Sponsor  Research institution and hospital 
 
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 A SIVA  Ayothidoss Pandithar Hospital  Room No 1, Department of Maruthuvam, National Institute of Siddha, Tambaram sanatorium, Chennai - 47.
Kancheepuram
TAMIL NADU 
9884662442
22381314
drashwinshiva.a@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NATIONAL INSTITUTE OF SIDDHA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J45||Asthma, (2) ICD-10 Condition: J454||Moderate persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  SIDDHA FORMULARY DRUG - SWASAKASA NEI   Dosage:30–60 drops(1.5 – 3ml) twice a day, Adjuvant: karkandu chooranam, Duration of treatment:13Days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  INCLUSIONCRITERIA:

1.Age between 18-60 years.
2.Sex: Male, Female & Transgender.
3.Patients with a clinical symptoms of Sneezing, Rhinitis, Dyspnoea, Cough with or without expectoration, Wheeze, Tightness of chest.
4.Wheezing more than 3 weeks.
5.Night time wheezing more than one day/week.
6.Asthma sometimes interferes with normal daily activities.
7.Patients who are willing to take radiological investigation and provide blood for lab investigation.
8.Patients who are willing to estimate volume of air forcibly expired after a deep inspiration by using PFT.
 
 
ExclusionCriteria 
Details 
1.Having covid-19 (or) past history of covid-19
2.Restrictive Lung diseases
3.Tuberculosis
4.Emphysema
5.Pleural effusion
6.Pneumothorax
7.Cardiac diseases and Renal diseases
8.Sleep apnea
9.Diabetic mellitus
10.Hypertension
11.Pregnancy
12.Lactation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Primary outcome is assessed by comparing the lung volumes and capacities in pre and post treatment of pulmonary function test reports.
2.The effect of “SWASAKASA NEI” in the bronchial asthma patients quality of life will be assessed through Asthma Quality of Life Questionnaire(AQLQ).
 
Total 12 Months
1) 1st - 3rd month - Screening and Enrollment of study population (patients).
2) 4th - 9th month - Conduct of the study
3) 10th month - Data collection
4) 11th month - Data analysis
5) 12th month - Outcome arrive and Journal publication.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Secondary outcome is assessed by comparing clinical signs and symptoms , laboratory parameters of IgE, Absolute Eosinophil Count ( AEC ) before and after treatment.
2.siddha basic principles like Envagai thervu, Neerkkuri and Neikkuri, and Udal thathukal ,Uyir thathukkal in swasakasam patients will be studied.
 
Total 12 Months
1) 1st - 3rd month - Screening and Enrollment of study population (patients).
2) 4th - 9th month - Conduct of the study
3) 10th month - Data collection
4) 11th month - Data analysis
5) 12th month - Outcome arrive and Journal publication.

 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/08/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

 In this clinical trial, patients reporting at OPD 1 Maruthuvam, Ayothidoss Pandithar Hospital, NIS with the clinical symptoms of difficulty in breathing, Rhinitis, cough with or without expectoration, sleeplessness, wheezing, chest tightness were examined clinically for enrolling in the study based on the inclusion and exclusion criteria. Patient Information Sheet and Informed Consent Form was issued to the patients. The patients enrolled in this study and informed about the objective of the study, Trial drug, possible outcomes in their own language and terms understandable to them. After ascertaining the patient’s willingness, informed consent were obtained in the consent form. All these patients were registered in A-HMIS and unique registration card was issued which contains information regarding patients’ Registration number, Address, Phone number and Doctors phone number etc. It can help to report easily if any adverse reactions arise. Complete clinical history, complaints and duration, examination findings all was recorded in the prescribed case report form (CRF). Screening Form- I was filled up; Form II was used for recording the patient’s history, clinical examination of signs and symptoms.  Form III was used for recording laboratory investigations respectively. Patients were advised to take the trial drug with an appropriate dietary advice given in form VIII 

On day 1 patient were advised to take oil bath with Chukku thylam or Peenisa thylam (required quantity)On day 2 the patient was advised to take purgative medication Agasthiyar kuzhambu â€“ 1 kundri (130 mg) with kadukkai kudineer at early morning in empty stomach.On day 3 patient is advised to take rest (without medication).From day 4 onwards the trial drug SWASAKASA NEI ( 1.5- 3 ml) was administrated orally after food twice a day.The trial drug “SWASAKASA NEI” 50ml was issued to the patient. The patients were asked to visit the OPD once in 7 days for clinical assessment. At each visit clinical assessment was recorded in the case report form(CRF) and the drug was issued.

CONCLUSION: In this study, trial drug showed significant improvement in all 30 patients. Therefore, this clinical trial purely indicates the trial drug is clinically effective in Bronchial asthma.The mean score of WBC, in before treatment was 8433.6 with standard deviation of 2217.5 and after treatment was 7814.2 with standard deviation of 2087.2.It was statistically significant (p = 0.002*) result with “t” value 3.4.The mean score of Eosinophil count,  before treatment was 6.4 with standard deviation of 3.8 and after treatment was 4.4 with standard deviation of 1.9. It was statistically significant (p <0.001**) result with “t” value 3.8.The mean score of ESR within 1 hr , before treatment was 17.1 with standard deviation of 12.6 and after treatment was 13.6 with standard deviation of 10.4. It was statistically significant (p <0.001**) result with “t” value 4.The mean score of Absolute Eosinophil count (AEC), before treatment was 580.7 with standard deviation of 412.3 and after treatment was 352.7 with standard deviation of 265.4. It was statistically significant (p <0.001**) result with “t” value 5.6.The mean score of Serum IgE level, before treatment was 1089.7 with standard deviation of 1156.3 and after treatment was 687.3 with standard deviation of 784.2. It was statistically significant (p <0.001**) result with “t” value 4.7.The mean score of PEFR, before treatment was 286.3 with standard deviation of 60.4 and after treatment was 345.3 with standard deviation of 80.8. It was statistically significant (p <0.001**) result with “t” value 7.2.Statistical analysis reveals the drug has more potential to reduce the elevated allergic and inflammatory mediators in blood. And, the Quality of life with decreased Peak expiratory flow rate was also markedly improved after treatment. There was no adverse reactions were reported during the course of this trial.The trial drugs are simple preparation with low cost and easily available plant materials. So, â€œSWASAKASA NEI” can be used in Bronchial asthma especially in Allergic types and Eosinophilia like conditions.

 
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