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CTRI Number  CTRI/2019/06/019936 [Registered on: 28/06/2019] Trial Registered Prospectively
Last Modified On: 20/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha
Other (Specify) [EXTERNAL POTTANAM THERAPY]  
Study Design  Other 
Public Title of Study   TO EVALUATE THE THERAPEUTIC EFFICACY OF “POTTANAM” AS EXTERNAL THERAPY and SIDDHA POLYHERBAL FORMULATION “AAYIL PATTAI CHOORANAM” (INTERNAL) IN THE TREATMENT OF “CEGANA VATHAM” (CERVICAL SPONDYLOSIS) 
Scientific Title of Study   An Open labelled non randomised Phase II comparative clinical trail to evaluate the therapeutic efficacy of POTTANAM (External therapy) and AAYIL PATTAI CHOORANAM (Internal) for CEGANA VATHAM (Cervical Spondylosis)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BKaruppannan 
Designation  PG Scholar 
Affiliation  Govt Siddha Medical College Hospital 
Address  Op.No 4, Department of Pura maruthuvam, Government Siddha Medical college and Hospital, Palayamkottai

Tirunelveli
TAMIL NADU
627002
India 
Phone  8072864062  
Fax    
Email  dr.karuppu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MAhamedMohideen 
Designation  Associate Professor 
Affiliation  Govt Siddha Medical College Hospital 
Address  Op.No 4, Department of Pura maruthuvam, Government Siddha Medical college and Hospital, Palayamkottai

Tirunelveli
TAMIL NADU
627002
India 
Phone  9442542282  
Fax    
Email  dr.ahmed63@gmail.com  
 
Details of Contact Person
Public Query  
Name  BKaruppannan 
Designation  PG Scholar 
Affiliation  Govt Siddha Medical College Hospital 
Address  Op.No 4, Department of Pura maruthuvam, Government Siddha Medical college and Hospital, Palayamkottai

Tirunelveli
TAMIL NADU
627002
India 
Phone  8072864062  
Fax    
Email  dr.karuppu@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  BKaruppannan 
Address  Op.No 4, Department of Pura maruthuvam, Government Siddha Medical college and Hospital, Palayamkottai 
Type of Sponsor  Other [PG Scholar Stipend] 
 
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 
BKaruppannan  Govt Siddha Medical College Hospital Tirunelveli  Op.No 4, Department of Pura maruthuvam, Government Siddha Medical college and Hospital, Palayamkottai
Tirunelveli
TAMIL NADU 		 8072864062

dr.karuppu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Govt Siddha Medical College Palayamkottai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M472||Other spondylosis with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  External therapy-Pottanam and Aayilpattai chooranam as internal medicine  External therapy-Pottanam and Aayilpattai chooranam- 2-3grms thrice a day for 48 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Neck pain
Radiating pain to the upper limbs
With or without numbness in the upper limbs
Giddiness and Neck Stiffness
Patient who are willing for admission and stay in IPD or willing to attend OPD
Patients who are Willing to give blood samples for laboratory investigations
 
 
ExclusionCriteria 
Details  Cervical rib
Trauma
Spina bifida
Ankylosing spondylosis
Tuberculosis in spine
Cardiac disease
• Other systemic illness
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparison of change from baseline in Oswestry Neck Disability Index at day 48 between Group I and Group II  48 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Assessment of safety parameters
2.Assessment of quality of life by EQ-5D
3.To evaluate the efficacy of the trial drug 		 48 days 
Assessment of safety parameters
Assessment of quality of life by EQ-5D
 		 GROUP I Intermittent external therapy
1st sitting 50% of symptoms will reduce
2nd sitting 80% of symptoms will reduce
GROUP II after giving internal medicine and external therapy 50% of symptoms will reduce within 22 days
80% of symptoms will reduce within 48 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   22/07/2019 
Date of Study Completion (India) 25/04/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Cervical spondylosis is a common degenerative condition of the cervical spine.It is most likely caused by age – related changes in the intervertebral discs. In Cervical spine,some degree of degenerative change is a normal radiological finding in the middle aged and elderly 
In Agasthiyar Attavanai Vagadam a drug AAYIL PATTAI CHOORANAM has been indicated for Vatha disease. Hence I have selected this polyherbal formulation AAYIL PATTAI CHOORANAM to evaluate the synergic therapeutic efficacy in the treatment of “CEGANA VATHAM” (CERVICAL SPONDYLOSIS) and also I have selected  â€œPOTTANAM”(Pouch)is one of the  best external therapies in Siddha system in alleviating pain in CeganaVatham is also evaluated the complementary therapy with trial medicines.


 
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