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CTRI Number  CTRI/2017/06/008938 [Registered on: 29/06/2017] Trial Registered Retrospectively
Last Modified On: 23/06/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   Study on navauppu mezhugu in dysmenorrhoea 
Scientific Title of Study   A pilot clinical trial to evaluate the therapeutic efficacy of the shastric siddha formulation navauppu mezhugu in soodhagavayu-dysmenorrhoea 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSathiyabama 
Designation  Pg scholar 
Affiliation  National Institute of Siddha 
Address  National institute of siddha Tambaram Sanatorium Chennai
National institute of siddha Tambaram Sanatorium Chennai
Kancheepuram
TAMIL NADU
600047
India 
Phone  9489912041  
Fax    
Email  dr.sathyabama27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrChristian 
Designation  Head of the department 
Affiliation  National Institute of Siddha 
Address  Department of noinaadal National institute of siddha Tambaram sanatorium chennai
National institute of siddha Tambaram sanatorium chennai
Kancheepuram
TAMIL NADU
600047
India 
Phone  9489912041  
Fax    
Email  Christianvijila@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrSathiyabama 
Designation  Pg scholar 
Affiliation  National Institute of Siddha 
Address  National institute of siddha Tambram sanatorium chennai
National institute of siddha Tambram sanatorium chennai
Kancheepuram
TAMIL NADU
600047
India 
Phone  9489912041  
Fax    
Email  dr.sathyabama27@gmail.com  
 
Source of Monetary or Material Support  
Siddha and Modern literature  
 
Primary Sponsor  
Name  Ayothidas pandithar hospital 
Address  National institute of siddha Tambram sanatorium Chennai 
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 
SATHIYABAMA  NATIONAL INSTITUTE OF SIDDHA  No 5 Department of noinaadal National institute of siddha Tambram sanatorium chennai
Kancheepuram
TAMIL NADU 		 9489912041

dr.sathyabama27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Lower abdominal pain or pelvic pain during menstrual cycle Backache,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Navauppu mezhugu  INGREDIENTS: 1.Suththi seitha Sotruppu(Sodium chloride) 2.Suththi seitha Indhuppu(Rock salt) 3.Suththi seitha Vediuppu(Potassium nitrate) 4.Suththi seitha kalluppu(Sodium chloride) 5.Suththi seitha Navatchaaram(Ammoni chloridum) 6.Suththi seitha Moongiluppu(Bamboo salt) 7.Suththi seitha Pooneeruppu(Fullers earth) 8.Suththi seitha Valaiyaluppu(Bentonite) 9.Suththi seitha Paaraiuppu 10.Suththi seitha veeram(Purified corrosive sublimate) 11.Suththi seitha rasakarpooram(Purified calomel) 12.Suththi seitha Milagu(Piper nigrum) 13.Suththi seitha Chukku(Zingiber officinale) 14.Suththi seitha Thippili(Pipr longum) Dose&Duration Pepper size(56mg) For 12 days - Morning after food with Notchi decoc. After 12 days of administration 4 days of holiday will be given •Treatment duration for each patient- 12 days/4 cycles 15. Suththi seitha nervaalam(Purified Croton cotyledons) - 10gm 16. Thuththi ver(Root of Abutilon indicum) - (Sufficient quantity) 17. Aatru thumatti chaaru(Colocynth juice) - (Sufficient quantity) 18. Thiripalai kizhayam - (Sufficient quantity) 19. Breast Milk(Cow’s milk+Sirukaanchori ver+chukku) - (Sufficient quantity) 20. Cow’s milk - (Sufficient quantity)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1) Lower abdominal or pelvic pain during menstrual cycle
2) Functional pain scale 3-5
3) Backache
 
 
ExclusionCriteria 
Details  1) Any major systemic illness
2) Hypertension
3) Renal disorder
4) Malignant tumor
5) vulnerable group
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improved pain score reduced from 5-3 to 0-2
No improvement pain score not reduced below 3 		 1) Total period – 1 1/2 years or till the completion of the study whichever is earlier
2) Recruitment for the study will be for 1 year.
3) Treatment duration for each patient- 12 days/4 cycles
4) Follow up period after drug treatment for each patient -2 months
5) Data entry analysis – 2 months
6) Report preparation and submission – 2months 
 
Secondary Outcome  
Outcome  TimePoints 
Complete clearance or reduction of size of uterine fibroids adenomyosis endometriosis ovarian cyst including associated symptoms
No clinical improvement 		 1) Total period – 1 1/2 years or till the completion of the study whichever is earlier
2) Recruitment for the study will be for 1 year.
3) Treatment duration for each patient- 12 days/4 cycles
4) Follow up period after drug treatment for each patient -2 months
5) Data entry analysis – 2 months
6) Report preparation and submission – 2months
 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   05/09/2016 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
  


Dysmenorrhoea means painful menstruation of sufficient magnitude so as to incapacitate day to day activities. These patients can be divided into two groups for understanding the pathogenesis of this distressing condition. Navauppu mezhugu a classical siddha medicine in siddha vaithiya thirattu is indicated for soodhaga vayu in particular. The investigator has interpreted this soodhaga vayu as to be Dysmenorrhoea and it is supported by the fact that this formulation is being used in clinical practice by many traditional physicians.


 
 
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