| CTRI Number |
CTRI/2022/11/047594 [Registered on: 24/11/2022] Trial Registered Prospectively |
| Last Modified On: |
21/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Amalgation of Manathakkali karpam and Yoga therapy for Asthma |
|
Scientific Title of Study
|
PHASE II NON RANDOMIZED COMPARATIVE OPEN CLINICAL
EVALUATION ON SWASAKASAM (BRONCHIAL ASTHMA) TREATED WITH
SIDDHAR YOGA THERAPY AND INTERNAL MANATHAKKALI KARPAM
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poorani U |
| Designation |
Pg scholar |
| Affiliation |
Government siddha medical college chennai |
| Address |
Post graduate
Department of siddhar yoga maruthuvam
Government siddha medical college
Chennai
Tamilnadu
Post graduate
Department of siddhar yoga maruthuvam
Government siddha medical college
Chennai
Tamilnadu
Chennai 106
Chennai
TAMIL NADU
600106
India |
| Phone |
7092120943 |
| Fax |
|
| Email |
pooranikamala111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saibudeen K |
| Designation |
Head of the department |
| Affiliation |
Government siddha medical college |
| Address |
Post graduate Room no S3
Department of siddhar yoga maruthuvam
Government siddha medical college
Chennai
TAMIL NADU
600 106
India |
| Phone |
9486041993 |
| Fax |
|
| Email |
drsaibudeen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poorani U |
| Designation |
Pg scholar |
| Affiliation |
Government siddha medical college chennai |
| Address |
Post graduate Room no S3
Department of siddhar yoga maruthuvam
Government siddha medical college
Chennai 106
Chennai
TAMIL NADU
600106
India |
| Phone |
7092120943 |
| Fax |
|
| Email |
pooranikamala111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College
Chennai
600106 |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college |
| Address |
6,anna arch road,NSK nagar, Arumbakkam, Chennai |
| 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 |
| U Poorani |
Government siddha medical college |
Postgraduate Room no S3 Department of Siddhar yoga maruthuvam
Chennai
TAMIL NADU |
7092120943
pooranikamala111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J452||Mild intermittent asthma, (2) ICD-10 Condition: J453||Mild persistent asthma, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manathakkali karpam , Reference: Theraiyar yamaga venba, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 60(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 48 Days, Reference: No, Route: NA, Dosage Form: Kwatha/ Kashaya, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Yoga therapy | Asanam
Sethubandasanam for three minutes
Komugasanam for three minutes
Marjariasanam for three minutes
Bhujangasanam for three minutes
Makarasanam for three minutes
Savasanam for three minutes
Pranayamam
Kabalaphati Pranayamam for two minutes
DHIYANAM
Aum chanting for three minutes
Duration 48 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patience having anyone of the following symptoms
Cough with or without expectoration
Wheezing
Dyspnoea |
|
| ExclusionCriteria |
| Details |
Congestive cardiac failure
Bronchiectasis
Chronic bronchitis
Status asthmaticus
Pregnancy and lactating mother
Any other serious systemic illnesses |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in symptoms of wheeze dyspnoea and chest tightness is assessed by
1. peak respiratory flow rate
2. low eosinophilic count
Comparing the clinical symptoms, corresponding radiological findings before and after treatment
|
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the time gap between the arisal of two asthma period |
48 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/11/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a non randomised comparative open clinical trial to study the safety and efficacy of siddha trial drug Manathakkali karpam(internal) and siddhar yoga therapy. Siddhar yoga Therapy is given to 20 patients (group 1) for 48 days.For group 2 patients (20 in numbers) Internal medication Manathakkali karpam in a dosage of 30 to 60 ml twice daily along with siddhar yoga therapy is to be given for 48 days |