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CTRI Number  CTRI/2024/12/078731 [Registered on: 30/12/2024] Trial Registered Prospectively
Last Modified On: 13/08/2026
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(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: -
2Intervention ArmDrugClassical(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)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/01/2025 
Date of Study Completion (India) 10/04/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 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 present study demonstrated that both Kasahara Dashemani Leha with Ghrita and Kasahara Dashemani Leha alone were effective in the management of Vataja Kasa in children. Significant improvement was observed in all assessed subjective parameters in both groups. Group A showed a higher overall improvement (96.32%) compared to Group B (89.49%), indicating a comparatively better clinical response with the addition of Ghrita. This may be attributed to the Snigdha and Vata-Pitta Shamaka properties of Ghrita, which may help counteract the dryness and aggravated Vata associated with Vataja Kasa.
However, intergroup comparison showed statistically insignificant differences in most parameters (p > 0.05). Therefore, although Group A demonstrated greater numerical improvement, the superiority of Ghrita as an adjuvant was not statistically established. Hence, the null hypothesis was accepted, indicating comparable efficacy of Kasahara Dashemani Leha with or without Ghrita. Overall, Kasahara Dashemani Leha appears to be an effective intervention for Vataja Kasa, while Ghrita may provide additional clinical benefit as a supportive Vata-Shamana and Snigdha adjuvant.
 
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