| CTRI Number |
CTRI/2022/08/044853 [Registered on: 23/08/2022] Trial Registered Prospectively |
| Last Modified On: |
06/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
A clinical trail to study the effect of nebulisation using ayurveda medicine in children with Bronchial asthma |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Bharngimool
Arka Nebulization And Sinhyadi Kwath In The Management Of Tamaka Shwasa In Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunaina |
| Designation |
PG Scholar |
| Affiliation |
Shri krishna govt ayurvedic College and hospital, kurukshetra, Haryana |
| Address |
Room no -99,P.G. Department of kaumarbhritya,Shri krishna govt ayurvedic College and Hospital,Sec -8 ,Umri Road,kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
09671423885 |
| Fax |
|
| Email |
324sunaina@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunaina |
| Designation |
PG Scholar |
| Affiliation |
Shri krishna govt ayurvedic College and hospital, kurukshetra, Haryana |
| Address |
Room no -99,P.G. Department of kaumarbhritya,Shri krishna govt ayurvedic College and Hospital,Sec -8 ,Umri Road,kurukshetra Haryana
HARYANA
136118
India |
| Phone |
09671423885 |
| Fax |
|
| Email |
324sunaina@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunaina |
| Designation |
PG Scholar |
| Affiliation |
Shri krishna govt ayurvedic College and hospital, kurukshetra, Haryana |
| Address |
Room no -99,P.G. Department of kaumarbhritya,Shri krishna govt ayurvedic College and Hospital,Sec -8 ,Umri Road,kurukshetra Haryana
HARYANA
136118
India |
| Phone |
09671423885 |
| Fax |
|
| Email |
324sunaina@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Governement Ayurvedic College and Hospital kurukshetra Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Shri Krishna Governement Ayurvedic College and Hospital kurukshetra |
| Address |
Shri Krishna Governement Ayurvedic College and Hospital Sec-8 Umri Road kurukshetra Haryana 136118 |
| 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 Amit Kataria |
Shri Krishna Governement Ayurvedic College and Hospital |
Room No - 99 PG Department of Kaumarbhritya Shri Krishna Governement Ayurvedic College and Hospital kurukshetra Umri Road Sec -8 Haryana 136118
Kurukshetra
HARYANA |
9034001230
dramitkataria@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Simhyadi kwath , Reference: Yog ratnakar , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Oral kwath | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Bharangi mool arka , Reference: NA, Route: Nasal, Dosage Form: Arka, Dose: 2(ml), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -arka nebulization for 15 minutes | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Bharangi mool arka , Reference: NA, Route: Nasal, Dosage Form: Arka, Dose: 2(ml), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - arka Nebulization for 15 min for 21 days |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of age group of 3 -16 years irrespective of caste, sex, religion.
2. Presence of classical symptoms of Tamak Shwasa like: Ghurghurkanvitam(wheezing), Shwasakashtata (shortness of breath), Aasino labhyate Saukhayam (relief in sitting position), Kasa(cough), Jawara abhibhut (associated with fever).
3. Parents of children are willing to participate in research trial.
|
|
| ExclusionCriteria |
| Details |
1.Patients presenting with severe symptoms of Tamak Shwasa (Bronchial asthma).
2. Any chronic illness, systemic disease like; TB, Respiratory Distress Syndrome, Chronic lung disease, Bronchiectasis, Pleurisy, CHD, Acute Diarrhoea,Septic Shock etc will be excluded from the study.
3. Children with any congenital abnormality.
4. History of food or drug allergy of any kind.
5. During course of treatment if the patient develops any acute illness requiring acute management, such patients will be excluded from the study and continued with conventional treatment.
6. Patients below age of 3 years and above 16 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in subjective and objective criterias of Tamaka Shwasa
|
Group A- 15 min of nebulization thrice a day for 21 days.
Route of administration - inhalation
Dose- 2 ml respule
Follow up - Follow up will be done monthly for two months
Group B - 15 min of nebulization thrice a day along with oral medication twice a day for 21 days.
Route of administration - inhalation and oral
Dose- 2 ml respule and 1.2ml/kg/day
Follow up - Follow up will be done monthly for two months . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To develop a safe and effective drug that can be helpful for asthmatic community.
2. To study etiopathogenesis of Tamak Shwasa from Ayurveda and Modern point of view.
3. To evaluate the effect of Pathya and Apathya counselling in the management of Tamak Shwasa.
|
2 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/09/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tamak Shwasa is one of the varities among five types of shwasa.It is mentioned as disease of pranvaha srotas. Environmental pollution comprising of excess smoke, dust particles, seasonal changes,extreem cold, pollen and toxic materials vitiate the prana vayu along with kapha. It can manifest either in vaigika or avaigika state due to presence of kapha vata dosha. With the expulsion of kapha patient gets relief for some time. Shodhana and shaman are used for its treatment. Shamana chikitsa will be used to treat children as Bharangi mool arka as herbal nebulizer and Sinhyadi kwatha for oral administration. Sinhyadi kwatha is mentioned in yoga ratnakar and Bharangi mool arka is taken for study. All children of age group 3 to 16 are selected from the opd of shri krishna govt ayurvedic College and hospital. Children below 3 and above 16,other chronic illnesses, children with congenital abnormality are excluded from the study. Maximum 30 patients are taken in two groups, each group has 15 patients. Group A is adviced for inhalation og Bharangi mool arka and group B is adviced for oral ingestion of Sinhyadi kwatha and inhalation of Bharangi mool arka. After completing the trial for 21 days children will be assessed again after 30 days for 2 months to access the efficacy of the trial. |