| CTRI Number |
CTRI/2024/12/078731 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of vatika kasa in children with kasahara dashemani leha. |
|
Scientific Title of Study
|
A clinical study on management of vatika kasa in children with kasahara dashemani leha with or without ghrita. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Koshaben B Purohit |
| Designation |
P G Scholar |
| Affiliation |
J S Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital |
| Address |
Department of Kaumarbhritya, J.S.Ayurveda Mahavidyalaya,P.D. Patel Ayurveda Hospital, college road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
7990258643 |
| Fax |
|
| Email |
princy.purohit8888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Rutu Patel |
| Designation |
Professor and HOD of Department of Kaumarbhritya |
| Affiliation |
J S Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital |
| Address |
Department of Kaumarbhritya, J.S.Ayurveda Mahavidyalaya,P.D. Patel Ayurveda Hospital, college road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8200426314 |
| Fax |
|
| Email |
drrutu8784@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Rutu Patel |
| Designation |
Professor and HOD of Department of Kaumarbhritya |
| Affiliation |
J S Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital |
| Address |
Department of Kaumarbhritya, J.S.Ayurveda Mahavidyalaya,P.D. Patel Ayurveda Hospital, college road, Nadiad
GUJARAT
387001
India |
| Phone |
8200426314 |
| Fax |
|
| Email |
drrutu8784@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurved teaching pharmacy of J.S. Ayurveda Mahavidyalayaand P.D.Patel Ayurveda hospital, Nadiad, Gujarat-387001, India |
|
|
Primary Sponsor
|
| Name |
J.S .Ayurveda Mahavidyalaya |
| Address |
Department of Kaumarbhritya, J.S.Ayurveda Mahavidyalaya,P.D. Patel Ayurveda Hospital, college road, Nadiad-387001 |
| Type of Sponsor |
Private 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 Koshaben B Purohit |
P.D. Patel Ayurveda Hospital |
Department of Kaumarbhritya, J.S.Ayurveda Mahavidyalaya,P.D. Patel Ayurveda Hospital, college road, Nadiad
Kheda
GUJARAT |
7990258643
princy.purohit8888@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE, MAM UNIVERSITY-NADIAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J989||Respiratory disorder, unspecified. Ayurveda Condition: KASAH, (2) ICD-10 Condition:J989||Respiratory disorder, unspecified. Ayurveda Condition: VATAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kasahara Dashemani leha with Goghrita, Reference: charaka sutrasthana ch4/16, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: -Ushnodaka), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kasahara Dashemani Leha , Reference: Charaka sutrasthana ch4/16, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: -Ushnodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of both genders belonging to age group 5 to 15years.
2.Patients of Vātaja Kāsa with symptoms like Shushka Kāsa (dry cough), Swarbheda (hoarseness of voice), Śiraḥśūla (headache), Pārśvaśūla and Urashool (pain in flank and chest region), Śuṣka mukha and Kaṇṭha (dryness of mouth and throat irritation) will be included.
3.Patient having frequent episodes of dry cough more than two months.
|
|
| ExclusionCriteria |
| Details |
1.Age below 5 years and above 15 years.
2.All types of Kāsa except Vātaja Kāsa Lakṣaṇa.
3.Patients having symptoms of likelihood of Tuberculosis and Asthma.
4.Cough with fever.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe and find out effect of kasahara dashemani leha with or without ghrita in vatika kasa in children. |
Baseline and 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/01/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study of Kasa is necessary as it can be associated with many complications if left untreated. For dry cough, which is correlated with Vataja Kasa, Antihistamines such as Cetirizine, Levocetirizine, Loratadine etc are generally used which causes various side effects in children. Hence there is a need to have an alternate treatment option which can provide the relief in sign and symptoms of the disease. So, Kasahara Dashemani Leha one of the herbal preparations has been proposed with or without Goghrita to assess its impact on vataja kasa patients in the current study.
|