| CTRI Number |
CTRI/2025/07/091944 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized comparative clinical trial to evaluate the efficacy of Khadirvasadi leha and
Dusparshadi awleha in the management of Vataj Kasa in children of age group 2 to 10
years. |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the efficacy of khadirvasadi leha and dusparshadi awleha in the management of vataj kasa in children of age group 2 to 10 years |
| 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 Rushikesh Prashant Tanpure |
| Designation |
PG Scholor |
| Affiliation |
PDEAS college of Ayurved and Research Centre , nigdi , Pune. |
| Address |
PDEAS Collage of Ayurveda and Research Centre Balrog Department third floor Nigdi , Pune.
Pune
MAHARASHTRA
411044
India
OPD no 118 Ayurved rugnalaya and Snowbell multi-speciality hospital, nigdi 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9075981152 |
| Fax |
|
| Email |
rushikeshtanpure461@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rushikesh Prashant Tanpure |
| Designation |
PG Scholor |
| Affiliation |
PDEAS college of Ayurved and Research Centre , nigdi , Pune. |
| Address |
PDEAS Collage of Ayurveda and Research Centre Balrog Department third floor Nigdi , Pune.
Pune
MAHARASHTRA
411044
India
OPD no 118 Ayurved rugnalaya and Snowbell multi-speciality hospital, nigdi 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9075981152 |
| Fax |
|
| Email |
rushikeshtanpure461@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Deodas |
| Designation |
Professor and HOD |
| Affiliation |
PDEAS College of Ayurved And Research Centre sector 25 pradhikaran nigdi Pune 411044 |
| Address |
PDEAS Collage of Ayurveda and Research Centre Balrog Department third floor Nigdi , Pune.
Pune
MAHARASHTRA
411044
India
OPD no 118 Ayurved rugnalaya and Snowbell multi-speciality hospital, nigdi 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS college of Ayurved and Research Centre , nigdi , Pune, Maharashtra 411044,India |
|
|
Primary Sponsor
|
| Name |
PDEAS college of Ayurved and Research Centre , nigdi , Pune. |
| Address |
PDEAS Collage of Ayurveda and Research Centre Balrog Department third floor Nigdi , Pune.
Pune
MAHARASHTRA
411044 |
| 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 Rushikesh Prashant Tanpure |
Ayurved Rugnalya And Snowbell Multi-speciality Hospital nigdi |
Kaumarbhritya department,OPD 118 Nigdi Pradhikaran Pune Maharashtra 411044
Pune
MAHARASHTRA |
9075981152
rushikeshtanpure461@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson institutional ethical commitee |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dusparshadi awleha , Reference: Research Article , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 36(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -koshna jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Khadirvasadi leha, Reference: Ayurved textbook - vangasena samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 36(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having classical signs and symptoms of Vataja Kasa. ( Any two or more
symptoms described in the context of Vataja Kasa eg. Shushka kasa, Shirashoola,
Swarabheda, Parshwashoola, Uroshoola, Shushka mukha and gala) irrespective of
gender, religion, socio-economic status, and between the age group of 3 to 10 years
will be taken.Subjects having Kasa with symptoms for less than 7 days duration. (acute cases only)
|
|
| ExclusionCriteria |
| Details |
Kasa as Anubandha Lakshan in other systemic diseases.Patients presenting with symptoms of Tamaka Shwasa in vega avastaha
(exaggerated bronchial asthma).
Kasa associated with Jwara.
Patients presenting with productive cough , foreign body inhalation/ingestion.
Patients who are k/c/o Koch’s, HIV, and other immunological diseases.
Patients k/c/o congenital anomalies |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of khadirvasadi leha and dusparshadi awleha in the management of vataj kasa complaints after 7 days |
To compare the efficacy of khadirvasadi leha and dusparshadi awleha in the management of vataj kasa complaints after 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe and compare the adverse effect if any . |
Follow up on 3rd, 5th and 7th day |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/08/2025 |
| 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
|
According to survey in india 41.6% patients of respiratory system disorders have cough
as a chief complaint , among whome childrens were 1.1%4
. The prevalence of cough in india is
5%- 10% .17
Cough is one of the primary symptom as well as independent vyadhi of pranvaha
strotas during childhood , it is one of the main reason to attend the hospital and further
frequent visits .In Ayu Samhitas disease kasa can be correlate with Cough .The Prana and
Udana Vayu are responsible for normal functioning of praanvahasrotas, which can be altered
due to causative factors in turn lead to manifestation of Kasa. Vataja kasa which is
characterized by these lakshanas Shuska gala, Shuska kasa with shuska alpa kapha,
Swarbheda, Parshav Shool, Shriashool, Urashool, Dourbalya etc.
Due the similarities of signs and symptoms, Vataja Kasa might be linked to dry
cough.Cough caused by URTI may be an upsetting indication for antitussive treatment in
regular users.Antitussives contain codeine or dextromethorphan, as well as
antihistamines,decongestants, are used to treat the symptoms .Kasa, despite it appears
simple, can progress to an illness with a poor diagnostic if neglected or mistreated .
Many herbal compositions for Kasa treatment were documented in Ayurveda.
According to Ayurveda, a single medicine is innsufficient to treat this ailment; hence palliative
preparations are made with a mix of drugs.
In the Charak samhita, Acharya Charak emphasised the use of Duhsparshadi Leha ,
while in vangasena Samhita emphasized the use of Khadirvasadi leha in Vataja Kasa. Katu,
Tikta, Kashaya rasatmaka, Laghu and Ruksha Gunatmaka, Ushna Viryatmaka, Katu Vipaki, and
most of them are Kapha-Vata Shamak (contribute to Samprapti), Deepen,
Pachan,Vatanulomana, Kasahara, and some have Tridosh hara qualities that play a big part
solving Kasa. |