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CTRI Number  CTRI/2023/11/059688 [Registered on: 08/11/2023] Trial Registered Prospectively
Last Modified On: 02/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study to compare efficacy of Abhyanga with Mahanarayana taila as an add on to the standard of care versus standard of care alone in chemotherapy induced peripheral neuropathy 
Scientific Title of Study   Abhyanga with Mahanarayana taila as an add on to the standard of care in chemotherapy induced peripheral neuropathy: a non-randomized clinical control trial 
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 Namboodiri Aiswarya Raman 
Designation  PG Scholar-2nd year- Department of Kayachikitsa 
Affiliation  Amrita School of Ayurveda 
Address  Amrita School of Ayurveda, Clappana PO, Amritapuri, Vallikkavu, Kollam

Kollam
KERALA
690525
India 
Phone  9789006880  
Fax    
Email  namboodiri.aishwarya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nagarajan C 
Designation  Professor- Department of Kayachikitsa, Guide 
Affiliation  Amrita School of Ayurveda 
Address  Amrita School of Ayurveda, Clappana PO, Amritapuri, Vallikkavu, Kollam

Kollam
KERALA
690525
India 
Phone  09447498812  
Fax    
Email  ammassankar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sreejith K 
Designation  Professor- Department of Kayachikitsa, Co-guide 
Affiliation  Amrita School of Ayurveda 
Address  Amrita School of Ayurveda, Clappana PO, Amritapuri, Vallikkavu, Kollam

Kollam
KERALA
690525
India 
Phone  9446127982  
Fax    
Email  sreejithk@ay.amrita.edu  
 
Source of Monetary or Material Support  
Amrita Institute of Medical Sciences, Ponekkara Rd, P. O, Edappally, Kochi, Ernakulam, Kerala 682041 
 
Primary Sponsor  
Name  Dr Namboodiri Aiswarya Raman 
Address  Amrita School of Ayurveda, Amritapuri, Clappana P.O. Kerala, India – 690 525 
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 
Dr Namboodiri Aiswarya Raman  Amrita Institute of Medical Sciences  Department of Oncology and Department of Integrative Medicine, Amrita Institute of Medical Sciences, Ponekkara Rd, P. O, Edappally, Kochi, Ernakulam, Kerala 682041
Ernakulam
KERALA 		 9789006880

namboodiri.aishwarya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Amrita Institute of Medical Sciences, Kochi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G620||Drug-induced polyneuropathy. Ayurveda Condition: TVAK^-GATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Charaka Samhita- Twaksthita vata chikitsa, Procedure details: Abhyanga, Allopathic Standard of Care Abhyanga with Mahanarayana taila, 10 ml, once daily, one hour before bath, for 21 days Standard of care- Tablet Etody etoricoxib 60mg once daily, oral administration, for 21 days)
(1) Medicine Name: Mahanarayana taila, Reference: Sahasrayogam, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 21 Days
2Comparator Arm (Non Ayurveda)-Etody etoricoxibStandard of care- Tablet Etody etoricoxib 60mg once daily, oral administration, for 21 days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Neuropathy attributed to chemotherapeutic agents with no prior history of attributable cause for chemotherapy induced peripheral neuropathy.

2)Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 3.

3)Self-reported neuropathy score greater than or equal to 3 on 0-10 scale and/or grade 2 or 3 neuropathy according to NCI-CTCAEv5 criteria.

4)Life expectancy more than 3 months.

5)Those who are willing to participate in this study and sign informed consent forms.  
 
ExclusionCriteria 
Details  1)Peripheral neuropathy other than those induced by neurotoxic chemotherapeutic agents.

2)Abnormal cognition and speech - causing difficulty in comprehension, expression and signing informed consent

3)Age below 18 and above 60 years.

4)Pregnancy, lactating mothers. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in symptoms of chemotherapy induced peripheral neuropathy based on:
1)FACT/GOG-NTX- Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity questionnaire
2)EORTC QLQ-CIPN20- The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-Item Scale
3)P-QAS- Pain Quality Assessment Scale 		 On 22nd day 
 
Secondary Outcome  
Outcome  TimePoints 
Change in grade of peripheral neuropathy based on NCI-CTCAEv5  On 22nd day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   19/11/2023 
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   This is a non randomized, clinical, control trial, comparing the efficacy of  Mahanarayana taila abhyanga ( on the affected parts- hands and/or feet) as and add on to the standard of care(60mg-1 tablet)( prescribed by the oncologist) compared to the administration of only the standard of care(60mg), daily, for 21 days, for chemotherapy induced peripheral neuropathy. The trial involves 30 participants suffering from chemotherapy induced peripheral neuropathy with 15 participants in each intervention and comparator group. The study will be conducted for 21 days in the Department of Oncology and Department of Integrative medicine at Amrita Institute of Medical Sciences , Kochi, Kerala. Primary and secondary outcomes will be measured on 22nd day after treatment. Primary outcome measure is changes in the symptoms of chemotherapy induced peripheral neuropathy measured using psychometric evaluation of the functional assessment of Cancer therapy / Gynecologic Oncology group- Neurotoxicity (FACT/GOG-NTX) questionnaire , Pain quality assessment (P-QAS) questionnaire and European organization for research and treatment of cancer quality of life questionnaire (EORTC QLQ-CIPN20). Secondary outcome measure observes change in grade of peripheral neuropathy based on NCI-CTCAE ( National cancer institute- common terminology criteria for adverse events) criteria. The study hypothesis is whether Abhyanga with Mahanarayana taila as an add on to the standard of care is effective in reducing the FACT-GOG, NCI-CTCAEv5, P-QAS and QLQ-CIPN20 scores of chemotherapy induced peripheral neuropathy in cancer patients between 18 to 60 years of age. 
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