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CTRI Number  CTRI/2022/03/040929 [Registered on: 09/03/2022] Trial Registered Prospectively
Last Modified On: 07/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   clinical trial to assess effect of ayurveda treatments in hand-foot skin reaction which occurs as a side-effect in patients taking chemotherapy 
Scientific Title of Study   AN OPEN LABEL CONTROL CLINICAL TRIAL TO ASSESS THE EFFECT OF AN AYURVEDA TREATMENT PROTOCOL CONTAINING PARISHEKA WITH YASHTIMADHU KASHAYA AND LEPANA WITH SHATADHAUTA GHRITA AS ADD ON THERAPY FOR HAND-FOOT SKIN REACTION IN CHEMOTHERAPY SUBJECTS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aiswarya S 
Designation  PG Scholar 
Affiliation  Amrita School of Ayurveda 
Address  Aiswarya S PG Scholar Department of Kayachikitsa Amrita School of Ayurveda Amrita Viswa Vidyapeetham Amritapuri Clappana P O

Kollam
KERALA
690525
India 
Phone  9940624913  
Fax    
Email  aiswaryasomaletha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr C Nagarajan 
Designation  Principal 
Affiliation  Amrita School of Ayurveda 
Address  Dr. C. Nagarajan, Principal, Amrita School of Ayurveda, Amritapuri, Amrita Viswa Vidyapeetham, India

Kollam
KERALA
690525
India 
Phone  9447498812  
Fax    
Email  ammassankar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr James Chacko 
Designation  Professor and HOD 
Affiliation  Rajiv Gandhi Ayurveda Medical College 
Address  Dr James Chacko Professor and HOD Department of Kayachikitsa Rajiv Gandhi Ayurveda Medical College Mahe Puducherry India

Mahe
PONDICHERRY
673311
India 
Phone    
Fax    
Email  drjameschacko.2008@gmail.com  
 
Source of Monetary or Material Support  
Amrita Institute of Medical Sciences, Ponekkara P.O, Kochi, Kerala 682041 India 
 
Primary Sponsor  
Name  Aiswarya S 
Address  Aiswarya S PG Scholar Department of Kayachikitsa Amrita School of Ayurveda Amrita Viswa Vidyapeetham Amritapuri Clappana P O Kerala 690525 
Type of Sponsor  Other [self] 
 
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 
Aiswarya S  Amrita Institute of Medical Sciences  Department of Oncology Amrita Institute of Medical Sciences Ponekkara P.O Kochi Kerala 682041
Ernakulam
KERALA 		 9940624913

aiswaryasomaletha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amrita Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L271||Localized skin eruption due to drugs and medicaments taken internally. Ayurveda Condition: Pitta Rakta Pradhana Agantuja Vrana in Hasta and Pada,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-1. pariSheka, परिषेक, 2. Lepana (Procedure Reference: sushruta samhita, Procedure details: As addon to Standard of Care, Kashaya Choorna will be provided to prepare Kashaya and perform Parisheka with sufficient quantity of Yashtimadhu Kashaya, for 15 mins twice daily from day 1 to day 30 of treatment. From day 6 to day 30, after Parisheka, Lepana should be done with sufficient quantity of Shatadhauta Ghrita over affected limbs twice daily.)
(1) Medicine Name: yashtimadhu kashaya choorna, Reference: sharangadhara samhita, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: bd, Duration: 30 Days
(2) Medicine Name: shatadhauta ghrita, Reference: sushruta samhita, Route: Topical, Dosage Form: Ghrita, Dose: 0(NA), Frequency: bd, Duration: 25 Days
2Comparator Arm (Non Ayurveda)-Standard of CarePatients will be prescribed medications for HFSR as per usual care practice.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Malignant tumour diagnosed by evidence of pathological or cytological findings
An Eastern Cooperative Oncology Group performance status ≤ 3
Treatment with Multi Kinase Inhibitors and occurrence of hand-foot skin reaction of any grade.
Life expectancy >3 months.
Those who are willing to participate in this study and sign informed consent forms. 
 
ExclusionCriteria 
Details  Dermatological toxicities not induced by Multi Kinase Inhibitors.
Concurrent acne vulgaris, eczema, psoriasis and other skin diseases.
Abnormal cognition and speech causing difficulty in comprehension, expression and informed consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the grade of
HFSR based on CTCAE v5.0 		 Before intervention : day 0
After intervention : day 31
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in severity of
pain according to VAS scale
2. Change in quality of life
according to HFQoL questionnaire. 		 Before intervention : day 0
After intervention : day 31 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="22" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   16/03/2022 
Date of Study Completion (India) 28/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 28/07/2022 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 30 participants from the OPD and IPD of Department of Medical Oncology, Amrita Institute of Medical Sciences, Kochi, will be enrolled after fulfilling the eligibility criteria and informed consent is obtained. All patients will undergo physical examination for assessment of severity of HFSR according to the CTCAE v5.0, measurement of pain by VAS Scale and patient reported HF-QoL questionnaire will be recorded. Group A (Study group) will be given, as addon to Standard of Care, Kashaya Choorna to prepare Kashaya and perform Parisheka with sufficient quantity of Yashtimadhu Kashaya, for 15 mins twice daily from day 1 to day 30 of treatment. From day 6 to day 30, after Parisheka, Lepana should be done with sufficient quantity of Shatadhauta Ghrita over affected limbs twice daily. Group B (control group) will be given Standard of care. After the end of treatment all the patients will again undergo physical examination for assessment of severity of HFSR according to the CTCAE v5.0, measurement of pain by VAS Scale and patient reported HF-QoL questionnaire will be recorded. 
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