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.

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 56mgwith 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.