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CTRI Number  CTRI/2024/08/072776 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 05/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   A Study to know the effect of Siddha medicine BavanaKadukkai (internal) and Sirasunoi peenisamsirasoolaiku thailam(mudithailam) in the treatment of peenisam (sinusitis) 
Scientific Title of Study   An Open Clinical Trial to evaluate the effectiveness of Siddha formulations Bavanakadukkai (Internal) and Sirasunoi peenisamsirasoolaiku thailam (mudithailam) in the management of peenisam (sinusitis)  
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 NPushpalatha 
Designation  II year pg scholar Department of Maruthuvam 
Affiliation  National Institute of Siddha 
Address  Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai

Chennai
TAMIL NADU
600047
India 
Phone  9789582396  
Fax    
Email  pushpalathanagarajan07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr H Nalini Sofia 
Designation  Associate Professor  
Affiliation  National Institute of Siddha 
Address  Room no 7 8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai

Chennai
TAMIL NADU
600047
India 
Phone  8939899363  
Fax    
Email  drhnalinisofia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr H Nalini Sofia 
Designation  Associate Professor  
Affiliation  National Institute of Siddha 
Address  Room no 7 8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai

Chennai
TAMIL NADU
600047
India 
Phone  8939899363  
Fax    
Email  drhnalinisofia@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha, Tambaram Sanatorium, Chennai-47 
 
Primary Sponsor  
Name  National Institute Of Siddha 
Address  Room no 7/8, Department of maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47 
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 
pushpalatha  Ayothidoss Pandithar Hospital  Room no 7 8 Department of maruthuvam national intitute of siddha tambaram sanatorium
Kancheepuram
TAMIL NADU 		 9789582396

pushpalathanagarajan07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J329||Chronic sinusitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bavanakadukkai(Internal) Sirasunoi peenisamsirasoolaiku thailam(mudithailam)  A Compound herbal drug tablet indicated to treat sinusitis advised to intake one tablet chewable before and after food twice a day for 48 days and mudithailam will be prescribed for oil bath in Sufficient quantity weekly twice 14 times for 48 days as per the text  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adults who are already diagnosed with sinusitis are included

Patient who has SNOT-22 Score above20
Patient who has radiological evidence of sinusitis 
 
ExclusionCriteria 
Details  Migraine

Patients who have tumours in PNS X-ray

Pregnancy and lactating mother

Patient with uncontrolled diabetes mellitus HBA1C 8.2 and hypertension systolic bp more than 180 and diastolic more than 110mmHg

Patient who are not willing to participate in the study will be excluded in this study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The outcome will be mainly assessed by reduction in clinical symptoms after the treatment by using sino- nasal outcome test-22  48 days 
 
Secondary Outcome  
Outcome  TimePoints 
Observe changes in clinical lab parameters ESR
IgE
AEC Pre and Post treatment 		 48 days 
 
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 2 
Date of First Enrollment (India)   30/08/2024 
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="1"
Months="0"
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  
BACKGROUND 
          Siddhars classified the diseases into 4448 types. Among them the diseases of nasal originare 86, one such disease is peenisam.The signs and symptoms of peenisam is mentioned in Yugi vaithya chinthamani such as headache, lacrimation, Nasal block, Nasal itching, ear discharge, running nose, cough with expectoration, absence of taste, may be correlated with sinusitis. Peenisam is otherwise known as Mookadaippu or Neerkovai as per Siddha Literature


                     Intake of cold water, exposure to chillness, inhalation of smoke, harmful and offensive gases, insomnia, speaking in loud voice, using contaminated water for bath, suppression of 14 natural urges (particularly vomiting & tears) Improper yoga practice which increases the body heat are the triggering factors to cause this disease. Sinusitis is the inflammation of the sinuses, which are air filled cavities in the skull. The types of sinuses are maxillary, frontal, ethmoid and sphenoid. Among these maxillary and ethmoid sinus quite often gets infected. The most frequently involved one is maxillary sinus

                                      The prevalence of sinusitis estimated to be 14% of the global population. Women 5.7% are highly affected compared to men 3.4% and increases with age. Approximately 0.5% to 2% adults and 6% to 13% children are complicated by bacterial sinusitis 1 in 8 Indians hit by chronic sinusitis.


                              In Siddha system, the line of treatment for Peenisa noi has been designed as internal medicines,external therapies such as Pattru,  Pugai, vedhu. By  following the siddha line of treatment for peenisam along with  proper dietary advise and life style modifications the recurrence rate of the disease and the need for expensive surgeries can be mitigated.



PRIMARY OBJECTIVE:

To evaluate the clinical effectiveness of siddha formulations Bavanakadukkai (internal) and sirasunoi peenisam sirasoolaiku thailam(mudithailam) in the management of sinusitis by using Sino-Nasal Outcome Test-22

SECONDARY OBJECTIVE:

To observe changes in clinical lab parameters-ESR, AEC and IgE pre and post treatment.

STUDY METHODOLOGY:

STUDY TYPE: Interventional study

STUDY DESIGN: An open clinical trial

STUDY PLACE: OPD of Ayothidoss pandithar hospital, National Institute of Siddha Tambaram sanatorium, Chennai-47.

STUDY PERIOD: 12 Months

SAMPLE SIZE: 30 patients
       

TREATMENT PLAN:

According to Siddha line of treatment,

Day 1: oil bath is advised

Day 2: Advised to take rest.

Day 3: Initiation of Internal medicine (Study Drug)

OILBATH: 
                        
  On day 1 patient will be advised to take oil bath with Sirasunoipeenisam sirasoolaikuthailam (sufficient quantity) as mudithailam.

 As per Siddha literature oil bath (Ennaimuzhukku) for males, Monday and Saturday, for females, Tuesday and Friday, weekly twice a day

DRUG FORMULATION:

Internal medicine: BAVANAKADUKKAI

Dosage : 1 Nos (500mg) chewable  before and after food, twice a 
day.

Duration : Orumandalam (48 days)

Reference : Siddha vaithiya thirattu page no:234

Author : Kuppuswamymudhaliyar & Uthamarayan

Edition year: 3rd edition, February 1998

Page No :68,69

Publication: Thamarai Noolagam, 7, N.G.O Colony, Vadapalani.


INCLUSION CRITERIA:

Adults who are already diagnosed with sinusitis are included...

Patient who has SNOT-22 Score above >20

Patient who has radiological evidence of sinusitis.

EXCLUSION CRITERIA:

Migraine

Patients who have tumours in PNS X-ray

Pregnancy and lactating mother.

Patient with uncontrolled diabetes mellitus HBA1C(>8.2%) and hypertension(>180/110mmHg)

Patient who aren’t willing to participate in the study will be excluded in this study.

WITHDRAWAL CRITERIA:

Intolerance to the drug and development of any adverse effect during drug trial.

Poor patient compliance & defaulters.

Patient unwilling to continue the course of clinical study

OUTCOME OF THE STUDY:

PRIMARY OUTCOME:

The outcome will be mainly assessed by reduction in clinical symptoms after the treatment by using sino- nasal outcome test-22(SNOT-22)

SECONDARY OUTCOME

Observe changes in clinical lab parameters (ESR,IgE, AEC) Pre and Post treatment.


RESULTS AND DISCUSSION: The results will be statistically analysed and reported

key words:peenisam , BAVANAKADUKKAI , SINUSITIS, SNOT-22
 
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