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CTRI Number  CTRI/2024/06/068796 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 21/01/2026
Post Graduate Thesis  No 
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 Nava Uppu Mezhugu and Peenisa thailam in the management of Peenisam(Sinusitis) 
Scientific Title of Study   A Clinical study to evaluate the effectiveness of Nava Uppu Mezhugu(Internal) and Peenisa thailam(External-Oil bath) in the management of Peenisam(Sinusitis) among Out-Patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennai-47. 
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 L Lohapriya  
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room No.7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai - 600047

Kancheepuram
TAMIL NADU
600047
India 
Phone  9600159204  
Fax    
Email  drlohapriyalakshmipathy@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 - 600047

Kancheepuram
TAMIL NADU
600047
India 
Phone  8939899363  
Fax    
Email  dr.h.nalinisofia@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 - 600047

Kancheepuram
TAMIL NADU
600047
India 
Phone  8939899363  
Fax    
Email  dr.h.nalinisofia@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha, Tambaram Sanatorium, Chennai - 600047. 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room No.7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai - 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 L Lohapriya  Ayothidoss Pandithar Hospital  Room No.7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai - 600047
Kancheepuram
TAMIL NADU 		 9600159204

drlohapriyalakshmipathy@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  NAVA UPPU MEZHUGU (INTERNAL) PEENISA THAILAM (EXTERNAL)  A compound herbal drug to treat Sinusitis with internal medicine at dose of 56mg twice a day and external medicine as required for 28 days 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants who has Adelaide Disease Severity Score above 12
Participants with radiological evidence(X-Ray PNS)
Participants with more than 3 clinical symptoms of sinusitis
 
 
ExclusionCriteria 
Details  Migraine
Diabetes
Acid peptic disease
Dental Carries
Pregnant Women

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in clinical symptoms after the treatment by Adelaide Disease Severity Score below 12.  28 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/06/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 AND RATIONALE OF THE STUDY

In Siddha system, the diseases of nasal origin are 86, one such disease is Peenisam otherwise known as Mookadaippu or Neerkovai. The signs and symptoms of Peenisam as mentioned in Yugi vaithya chinthamani such as headache, lacrimation, sneezing, nasal block, nasal itching, clogged ears, itchy ears, running nose, postnasal drip, absense of taste, may be correlated with sinusitis in bio medicine. Intake of cold water, exposure to chillness, inhalation of smoke, harmful and offensive gases, using contaminated water for bath, suppression of 14 natural urges (particularly vomiting &tears), Improper yoga practise 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.

ü  Acute Sinusitis is defined as symptom of less than 4 weeks of duration.

ü  Sub acute sinusitis: Defined as symptoms of 4 to 8 weeks duration

ü  Chronic sinusitis: Defined as symptoms lasting longer than 8 weeks.

ü  Recurrent acute sinusitis: Defined as three or more episodes per year with each episode lasting less than 2 weeks.

Internal therapies and External therapies are two eyes of Siddha system. In several instances, only the procedures without any drug are sufficient and these procedures are already systematized. Most of the therapies are aimed at maintaining healthy balance of the three physiological factors and also seven tissues of the body.

The prevalence of sinusitis estimated to be 14.7% of the global population. According to annual report of NIS, the patients visiting for the management of sinusitis in the year 2021, 2022, 2023 is 1403, 8522, 16372 patients which increasing yearly. This trial may provide an alternate option for many patients since surgery is the most suggested intervention in modern medicine. Moreover, most of the components of the interventional drug contains herbs that have anti-inflammatory, anti-oxidant, immunomodulatory, analgesic and anti-microbial action as mentioned in Siddha texts and various research articles. Hence I had chosen Siddha formulation “Nava Uppu Mezhugu” and “Peenisa thailam” for the management of “Peenisam (Sinusitis)”

OBJECTIVE

To evaluate the clinical effectiveness of Nava Uppu Mezhugu (Internal) and Peenisa thailam (External-Oil Bath) in the management of Peenisam (Sinusitis) among outpatients attending Ayothidoss Pandithar Hospital, National Institute of Siddha by reduction in the clinical symptoms after the treatment using Adelaide Disease Severity Score.


STUDY DESIGN

An open non randomized clinical study

STUDY PLACE

OPD of Ayothidoss Pandithar Hospital,

National institute of Siddha, Chennai-47

STUDY PERIOD

6 months (Clinical study – 4 months

                Data analysis – 1 month)

      Project submission – 1 month)

SAMPLE SIZE

Actual sample size – 15


 INCLUSION CRITERIA

ü Age: 18-60 years

ü All Genders

ü Participants who has  Adelaide Disease Severity Score above 12

ü Participants with radiological evidence (X-Ray PNS)

ü Participants with more than 3 clinical symptoms of sinusitis


EXCLUSION CRITERIA

·       Migraine

·       Diabetes

·       Acid peptic disease

·       Dental Carries

·       Pregnant Women

 

WITHDRAWL CRITERIA

v Intolerance to the drug and development of any serious adverse effect during the study (Participants having symptoms of Abdominal pain, Oral ulcers, Vomitting and Diarrhea).

v Poor participant compliance (not taking medicines for more than a week) and defaulters.

v Participant unwilling to continue the course of clinical study.

INTERVENTIONAL MEDICINE

INTERNAL MEDICINE

            Nava Uppu Mezhugu

INDICATION

Neerkovai

DOSAGE

          56 mg (Milagalavu) with Panai vellam twice a day

DURATION

28 Days

REFERENCE

Siddha Vaidhya Thirattu, Pg. No. 189,190,191

EXTERNAL MEDICINE - OILBATH

            Peenisa thailam

INDICATION

Peenisa Noigal


TREATMENT PLAN

ü On 1st day the participant will be asked to take External medicine as Oil bath with Peenisa thailam (Required quantity).

ü On 2nd day the participant will be asked to take the laxative drug prescribed ( Agasthiyar kuzhambu 130mg with ginger juice 10ml at early morning in empty stomach).

ü On 3rd day the participant will be advised to take rest without medication.

ü From 4th day Internal medicine Nava Uppu Mezhugu will be given at a dose of 56mg with Panai vellam, twice a day and External medicine Peenisa Thailam will be given to take oil bath weekly once for the period of 28 days.

ü The participant is strictly advised to follow proper diet for all 28 days.

ü The participant are advised to visit the OPD after 28 days. The clinical assessment will be recorded in prescribed proforma.

ü The laboratory investigations will be done before and after treatment and recorded in prescribed format.


OUTCOME

          The Primary outcome will be mainly assessed by reduction in clinical symptoms after the treatment by Adelaide Disease Severity Score below 12.


RESULT AND DISCUSSION

The results will be published based on statistical analysis.



 
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