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CTRI Number  CTRI/2024/07/070655 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   EFFECT OF SIDDHA MEDICINE PANJAMOOLA KUDINEER IN PATIENTS WITH SURATHODAM (CHRONIC FATIGUE SYNDROME) 
Scientific Title of Study   Effect of Panjamoola Kudineer on Surathodam (Chronic Fatigue Syndrome) in patients attending OPD at Government Siddha Medical College Hospital, Chennai - A Pilot Study. 
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 G Sanjana 
Designation  Pg Scholar 
Affiliation  Government Siddha Medical College, Chennai. 
Address  Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai -106.

Chennai
TAMIL NADU
600106
India 
Phone  8939311792  
Fax    
Email  sanjugopi1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr U Chithra 
Designation  Lecturer, Department of PG Pothu Maruthuvam 
Affiliation  Government Siddha Medical College, Chennai. 
Address  Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  9445716802  
Fax    
Email  mmsankar2000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr U Chithra 
Designation  Lecturer, Department of PG Pothu Maruthuvam 
Affiliation  Government Siddha Medical College, Chennai. 
Address  Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai.


TAMIL NADU
600106
India 
Phone  9445716802  
Fax    
Email  mmsankar2000@gmail.com  
 
Source of Monetary or Material Support  
Government Siddha Medical College, No-6, Anna Arch Road, Arumbakkam, Chennai - 600106. 
 
Primary Sponsor  
Name  Government Siddha Medical College, Chennai 
Address  No-6, Anna Arch Road, Arumbakkam, Chennai - 600106 
Type of Sponsor  Government 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 G Sanjana  Government Siddha Medical College.  Department of PG Pothu Maruthuvam, Room No. S1, Government Siddha Medical College Hospital, Arumbakkam,Chennai 600106
Chennai
TAMIL NADU 		 8939311792

sanjugopi1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethical Committee, Arumbakkam, Chennai.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B949||Sequelae of unspecified infectiousand parasitic disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil   Nil 
Intervention  Panjamoola Kudineer  60ml, Twice a day, Before food for 48 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.All gender aged above 18 to 60 years
2.Past history of fever before 6 months with unexplained Fatigue and Malaise that persists for 6 or more months with neuropsychiatric symptoms including slight fever, headache, weakness, impaired thinking and depression. 
 
ExclusionCriteria 
Details  1.Past history of Fever before 6 months with no associated symptoms of Chronic Fatigue Syndrome.
2.Patient who does not meet the diagnostic criteria of CCC.
3.Patients with any other chronic systemic illness.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome is mainly assessed by reduction in clinical symptoms of Surathodam
(Chronic Fatigue Syndrome). 		 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in clinical symptoms of Surathodam
(Chronic Fatigue Syndrome) measured by CANADIAN CONCENSUS CRITERIA 		 1 month 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   22/07/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Nil

  6. For how long will this data be available start date provided 05-06-2026 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Chronic fatigue syndrome (CFS) is characterized by unexplained fatigue and malaise that persist for more than 6 months with neuropsychiatric symptoms, including slight fever, headache, weakness, impaired thinking, and depression. The onset and severity of these symptoms vary and reduce the quality of life as well as social, occupational, and personal activities of those affected, with some becoming bedridden. In Siddha system of medicine, the signs and symptoms manifested in the criteria of CCC can be correlated with “Sura Noyil pirakkum thunai noigal”.According to T.V.Sambasivam Pillai tamil-english dictionary, “Surathodam” or “Surakodhu” refers to vitiation caused by fever. As the literary evidences support the usage of PANJA MOOLA KUDINEER can be safe and effective option to relieve Surathodam (Chronic Fatigue Syndrome) of patients.


 
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