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CTRI Number  CTRI/2025/02/080249 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   An Observational Study to Evaluate the Effect of Siddha Formulations in reducing Chemoradiotherapy-Induced side effects in Cancer Patients 
Scientific Title of Study   A Prospective Comparative Observational Study to Evaluate the Effectiveness of Siddha Formulations in Alleviating Chemoradiotherapy-Induced Adverse Effects(Toxicity) in Cancer Patients Attending the OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha 
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 V Harini Priya 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room no 26/27, Department of Nanju Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai, TAMIL NADU 600047, India

Chennai
TAMIL NADU
600047
India 
Phone  8056708005  
Fax    
Email  harinivenkatesh28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S Murugesan 
Designation  Associate professor 
Affiliation  National Institute of Siddha 
Address  Room no 26/27, Department of Nanju Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai, TAMIL NADU 600047, India

Chennai
TAMIL NADU
600047
India 
Phone  9841108269  
Fax    
Email  ss.drss@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S Murugesan 
Designation  Associate professor 
Affiliation  National Institute of Siddha 
Address  Room no 26/27, Department of Nanju Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai, TAMIL NADU 600047, India

Chennai
TAMIL NADU
600047
India 
Phone  9841108269  
Fax    
Email  ss.drss@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha, Tambaram Sanatorium, Chennai - 600 047 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room no 26/27, Department of Nanju Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai, TAMIL NADU 600047 
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 V Harini Priya  Ayothidoss Pandithar Hospital  Room no 26/27, Department of Nanju Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai, TAMIL NADU 600047
Chennai
TAMIL NADU 		 8056708005

harinivenkatesh28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee , National Institute of Siddha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C800||Disseminated malignant neoplasm, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Diagnosed cases of carcinoma under Radiotherapy or Chemotherapy or Both, and post radiation participants with symptoms.
Those complaining of one or more Adverse effects Such as Nausea, vomiting, Mucositis, Fatigue, Xerostomia, Tastelessness, Skin reaction, Alopecia.
Patients who are willing to give informed consent.
 
 
ExclusionCriteria 
Details  Pregnant Or lactating women
Patients not willing to give informed consent.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The effectiveness of the therapy of Group A and Group B will be compared before and
after treatment by comparing the reduction in the adverse effects of the chemo-
radiotherapy , using grades. 		 Study commencement and conduct of the study - 15 Months
Outcome Assessment - 3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Safety to be assessed by LFT , RFT and haemotological parameters Such as
Haemoglobin. 		 Study commencement and conduct of the study - 15 Months
Outcome Assessment - 3 Months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   21/02/2025 
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="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   INTRODUCTION :

Cancer has emerged as a leading cause of morbidity and mortality worldwide, prompting significant advancements in treatment modalities. Chemotherapy and radiotherapy remain central to modern oncological therapy, offering substantial hope for survival and disease management. However, the harsh reality of these interventions is their associated adverse effects, which pose significant challenges to patient’s quality of life. Addressing these side effects has become a crucial aspect of comprehensive cancer care. In this context, the exploration of complementary and alternative therapies has gained considerable attention. Siddha medicine, a traditional system of healing from South India, presents a potentially valuable approach to managing these adverse effects. This study aims to investigate the efficacy of Siddha treatments in alleviating the adverse effects caused by chemotherapy and
radiotherapy, offering a novel perspective on integrative cancer care.
Siddha medicine utilizes a diverse array of medicinal herbs, each selected for its specific therapeutic properties. Many of these herbs have demonstrated potential in managing symptoms such as nausea, fatigue, and skin conditions, which are common among cancer patients undergoing conventional treatments. Additionally, Siddha practices emphasize the importance of individualized dietary recommendations and lifestyle adjustments, aimed at supporting overall health and enhancing the body’s natural healing processes. Detoxification, another key component of Siddha medicine, focuses on removing accumulated toxins from the body, which is believed to improve resilience and overall well-being.

AIM :

The aim of my study is to Evaluate the Effectiveness of Siddha Formulations in Alleviating Chemoradiotherapy-Induced Adverse Effects(Toxicity) in Cancer Patients.

PRIMARY OBJECTIVE :

To evaluate and compare the effectiveness of Siddha combinations A and B in the management of Chemo-radiotherapy induced Adverse effects in cancer patients by Assessing the parameters of the Adverse effects.

SECONDARY OBJECTIVE :

To assess the LFT ,RFT, and haemotological parameters such as Haemoglobin.

STUDY DESIGN :

Prospective Comparative Observational Study

OUTCOME OF THE STUDY :

The effectiveness of the therapy of Group A and group B will be compared before and after treatment by comparing the reduction in the adverse effects of the chemo- radiotherapy , using grades.


Safety to be assessed by LFT , RFT and haemotological parameters Such as Haemoglobin.




 
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