| CTRI Number |
CTRI/2021/05/033620 [Registered on: 13/05/2021] Trial Registered Prospectively |
| Last Modified On: |
05/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study on the efficacy of Kushmanda Rasayana and Vasa Avaleha in the management of Kasa (cough) in children |
|
Scientific Title of Study
|
“A COMPARATIVE CLINICAL STUDY ON THE EFFICACY OF KUSHMANDA
RASAYANA AND VASA AVALEHA IN THE MANAGEMENT OF KASA 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 |
Indu Nandal |
| Designation |
PG Scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra |
| Address |
Room No. 99, PG Department of Kaumarbhritya, Shri Krishna Govt. Ayurvedic College, umri road sector 8 kurukshetra
Room No. 99, PG Department of Kaumarbhritya, Shri Krishna Govt. Ayurvedic College, umri road sector 8 kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7277777694 |
| Fax |
|
| Email |
dr.indu0001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kataria |
| Designation |
Associate Professor |
| Affiliation |
Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra |
| Address |
Room No. 99, PG Department of Kaumarbhritya, Shri Krishna Govt. Ayurvedic College, umri road sector 8 kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9354443131 |
| Fax |
|
| Email |
dramitkataria@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Indu Nandal |
| Designation |
PG Scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra |
| Address |
Room No. 99, PG Department of Kaumarbhritya, Shri Krishna Govt. Ayurvedic College, umri road sector 8 kurukshetra
Room No. 99, PG Department of Kaumarbhritya, Shri Krishna Govt. Ayurvedic College, umri road sector 8 kurukshetra
HARYANA
136118
India |
| Phone |
7277777694 |
| Fax |
|
| Email |
dr.indu0001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra |
|
|
Primary Sponsor
|
| Name |
Shri Krishna Govt Ayurvedic College and Hospital Kurukshetra |
| Address |
Shri Krishna Govt. Ayurvedic College and Hospital, umri road sector 8 Kurukshetra 136118 |
| Type of Sponsor |
Other [self] |
|
|
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 Govt. Ayurvedic College and Hospital, Kurukshetra |
Room No. 99, PG Department of Kaumarbhritya, Shri Krishna Govt. Ayurvedic College, umri road sector 8 kurukshetra
Kurukshetra
HARYANA |
9354443131
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:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KUSHMANDA RASAYANA |
Dose: fixed according to Young’s rule:
Route : Orally
Aushadhakala: Abhakta twice a day
Anupana: Koshna jala / dugdha
Duration of treatment: 4 weeks
Follow up: 4 weeks |
| Comparator Agent |
VASA AVALEHA |
Dose: fixed according to Young’s rule:
Route : Orally
Aushadhakala: Abhakta twice a day
Anupana: Koshna jala / dugdha
Duration of treatment: 4 weeks
Follow up: 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
• Patients presenting with the classical symptoms of Kasa as per their Dosha variety (Vataja, Pittaja,
Kaphaja) since 2 weeks.
• Children of age group of 3 -16 years.
• Patients of either sex. |
|
| ExclusionCriteria |
| Details |
• Patients presenting with symptoms of Tamaka Shwasa (Bronchial asthma), Kshayaja and Kshataja
Kasa.
7
• Serious cardiovascular, cerebrovascular, renal and liver diseases or severe illness.
• Any chronic illness diseases of respiratory system eg. TB, Respiratory Distress Syndrome, Chronic
lung disease, Bronchiectasis, Pleurisy etc.
• Patients suffering from any systemic disorder (like Diabetes Mellitus etc.) and Kasa as a
complication of any disease will be excluded from the study.
• Children with any congenital abnormality.
• History of food or drug allergy of any kind.
• During course of treatment if the subject develops any acute illness requiring acute management,
such patients will be excluded out of the study and continued with conventional treatment.
• 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 |
1. To study conceptually the aetiopathogenesis of Kasa occurring in children contemplating from both
Ayurveda and Modern view point.
2. To compare and assess the efficacy of the drugs in the management of the Kasa clinically. |
Dose: fixed according to Young’s rule
Route : Orally
Aushadhakala: Abhakta twice a day
Anupana: Koshna jala / dugdha
Duration of treatment: 4 weeks
Follow up: 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the role of instructions formulated in ayurvedic and modern literature for controlling the Kasa (general instructions and Pathya-Apathya). |
Dose: fixed according to Young’s rule
Route : Orally
Aushadhakala: Abhakta twice a day
Anupana: Koshna jala / dugdha
Duration of treatment: 4 weeks
Follow up: 4 weeks |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2021 |
| 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
|
Kasa is the most frequently encountered problem in the Balyavastha (Pediatric age). Since Kapha is the main culprit in production of Kasa (cough) and Kapha Dosha is dominating in Balyavastha, the incidence is more in this age group. Early intervention is necessary in case of Kasa as it is a Nidanarthakara Vyadhi to produce Kasa and Kshaya. If Pratishyaya and Kasa are not managed properly, it will lead to severe and complicated conditions mentioned by Acharya Charaka like –Akshiroga, Apeenasa, Khalitya, Nasapaka, Shiroroga, Shravanaroga, Parisrava, Dushta Pratishyaya . Keeping in view above facts this study was planned to explore the efficacy of Kushmanda Rasayana and Vasa Avaleha in the management of Kasa in children†and to provide a simple, safe and cost-effective remedy without having any adverse effect on the health of children. All children will be selected from OPD and IPD of Shri Krishna Govt. Ayurvedic College and Hospital, Kurushtera. Children of age group of 3 -16 years with the classical symptoms of Kasa as per their Dosha variety (Vataja, Pittaja, Kaphaja) since 2 weeks will be selected. Maximum 60 patients in two groups, each comprising of 30 patients. Group A : (Kushmanda Rasayana) had 30 patients and Group B : (Vasa Avaleha) had 30 patients. Medicine will be given orally, twice a day for 4 weeks. Follow up will be done for 4 weeks. Dose will be fixed according to Young’s rule |