An Open Clinical Trial to evaluate the effectiveness of Siddha formulations Bavanakadukkai (Internal) and Sirasunoi peenisamsirasoolaiku thailam (mudithailam) in the management of peenisam (sinusitis)

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