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CTRI Number  CTRI/2025/03/083006 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 04/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of two drugs Desmodium triquetrum and Shalaparni (Desmodium gangeticum) in the patients suffering from cough (Kasa) 
Scientific Title of Study   Evaluation of Kasahara Karma of Desmodium triquetrum (L.) DC. as an alternative to Shalaparni (Desmodium gangeticum (L.) DC.) therapeutically 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha Amol Kandade 
Designation  MD Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Room no. 327, Department of Dravyaguna, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 361008

Jamnagar
GUJARAT
361008
India 
Phone  7506637777  
Fax    
Email  nehakandade@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Bhupesh R Patel 
Designation  Professor and HOD 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Room no. 329, Department of Dravyaguna, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 361008

Jamnagar
GUJARAT
361008
India 
Phone  7487876343  
Fax    
Email  brpayu@itra.edu.in  
 
Details of Contact Person
Public Query  
Name  Neha Amol Kandade 
Designation  MD Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda 
Address  Room no. 327, Department of Dravyaguna, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 361008

Jamnagar
GUJARAT
361008
India 
Phone  7506637777  
Fax    
Email  nehakandade@gmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda, Jamnagar 361008 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda 
Address  Department of Dravyaguna, Institute of Teaching and Research in Ayurveda, Opposite to B division police station, Jamnagar 361008 
Type of Sponsor  Research institution and hospital 
 
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 Neha Kandade  Institute of Teaching and Research in Ayurveda Hospital  OPD No. A 1, Department of Dravyaguna, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 361008
Jamnagar
GUJARAT 		 7506637777

nehakandade@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R05||Cough. Ayurveda Condition: KASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Desmodium triquetrum, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Shalaparni (Desmodium gangeticum), Reference: Bhavaprakasha Nighantu, Guducyadi varga Ver. 31 to 33, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients having chief complaint of Kasa and showing minimum 2 classical signs and symptoms of Vataja, Pittaja or Kaphaja Kasa described in classical Ayurvedic Texts.
2. Newly diagnosed cases of Kasa.
3. Uncomplicated cases of Kasa.
4. Age group of 18 to 60 years.
5. Chronicity less than 1 month.
 
 
ExclusionCriteria 
Details  1. Patients suffering from any systemic disorders (like Tuberculosis, Asthma and others) and having Kasa as a complication of any disease will be excluded from the study.
2. Asadhya (incurable) or Yapya Kasa (manageable cough) like Kshayaja (produced by tissue destruction) and Kshataja (produced by injury).
3. Other complicated respiratory diseases having any organic lesion such as tumor or any anatomical defect in airway.
4. Uncontrolled systemic disorders like Hypertension (having blood pressure more than 160/100 mm of Hg), Diabetes Mellitus (having RBS more than 180 mg/dl).
5. Pregnant women and lactating mothers.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms will be assessed on the basis of changes in scoring patterns developed for grading of the clinical factors on 0th and 7th day.   7th day  
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  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 
Date of First Enrollment (India)   01/05/2025 
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="0"
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   This trial is a randomized controlled clinical trial to evaluate the Kasahara Karma of Desmodium triquetrum Panchanga Kwatha  as an alternative to Shalaparni (Desmodium gangeticum) Panchanga Kwatha. The selected patients will be divided into two groups of 20 patients each, on the basis of computer generated randomization and will receive the drug in the dosage of 25ml Kwatha after food twice a day for one week. 
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