| 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 |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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. |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NATIONAL INSTITUTE OF SIDDHA |
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: J45||Asthma, (2) ICD-10 Condition: J454||Moderate persistent asthma, |
|
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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.
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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.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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.
|
|
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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.
|
|
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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 – 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, “SWASAKASA NEI†can be used in Bronchial asthma especially in Allergic types and Eosinophilia like conditions. |