A clinical study to evaluate the effectiveness of Siddha herbal formulation Nilavagai Chooranam(BKC) in the treatment of Moolam (Internal Haemorrhoids) AMONG out-patients attending ayothidoss pandithar hospital, national institute of siddha, chennai-47

BACKGROUND:

Siddha system of medicine is one of the holistic healing sciences among the traditional systems of medicine in India. It ensures everyone to lead a disease-free healthy life. Siddhars classified the human diseases as 4448 in number. Anorectal diseases are one among them. Under the spectrum of anorectal diseases sage Yugi mentioned the disease Moolam and its 21 types in Yugi Vaidhya Chinthamani.

In Siddha, Moolatharam is mentioned as one of the 6 pillars and six psychic centers in the human body. It is said to be located near the coccygeal plexus beneath the sacrum which is the principal axis of the body. According to Thiridhosha theory, derangement of both Vatham and Pitham Humour is attributed as etiological factor for moolam.

In Moola noi, deranged Vatha humor trigers keelvai kanal(abana vaayu) which in turn stimulates pitham humor resulting in Moolam. With the symptoms of constipation, bleeding during defecation, pain in umbilical region, pallor of the body, headache, giddiness are developed.

Haemorrhoids are a very common anorectal condition defined as the symptomatic enlargement and distal displacement of the normal anal cushions. Clinically there are two types of Haemorrhoids viz. Internal Haemorrhoids and External Haemorrhoids. Internal Haemorrhoids arises from superior venous plexus above the Hiloton’s line covered by columnar epithelium. External Haemorrhoids arises from inferior venous plexus below the Hiloton’s line covered by squamous epithelium. Based upon the protrusion of mass, it’s subdivided into 4 stages.

Etiological factors include Constipation, a low fiber diet, a sedentary lifestyle, a high Body Mass Index, pregnancy, hereditary and are often assumed to increase the risk of hemorrhoidal disease (HD). The common presenting symptoms of haemorrhoids are the painless rectal bleeding, pruritus, fecal soilage, perianal irritation, or mucus discharge. Usual treatments provided for Haemorrhoids are conservative management includes stool softeners, bulking agents for stage 1 and 2. Conditions Refractory to conservative management or stage 3 and 4 Haemorrhoids will be treated surgically. The recurrence rate after stapled hemorrhoidopexy and conventional hemorrhoidectomy 0 to 26 % and 0 to 10.8 %, respectively; reoperation rate was 16.7 % after stapled hemorrhoidopexy.

In Siddha system, the line of treatment for Moola noi has been designed as internal medicines, external therapies such as Kattu, Pattru, Poochu, Pugai, Kalimbu, Neer and Yoga maruthuvam. By following the siddha line of treatment for moolam along with proper dietary advise, the recurrence rate of the disease and the need for expensive surgeries can be mitigated.

OBJECTIVE:

To evaluate the effectiveness of siddha herbal formulation NILAVAGAI CHOORANAM(BKC) in the treatment of MOOLAM (INTERNAL HAEMORRHOIDS) patients through proctoscopy and haemorrhoid symptom scoring (HSS) before and after treatment.

STUDY DESIGN:

Interventional study (An Open, non-randomized Clinical Study)

STUDY PLACE:

OPD of AyothidossPandithar Hospital,

National Institute of Siddha,

TambaramSanactorium,

Chennai -47.

SAMPLE SIZE:

30 Patients

STUDY PERIOD:

12 Months

TREATMENT PLAN:

According to Siddha line of treatment,

• Day 1: Oil bath is advised.

• Day 2: Gentle Laxative is advised

OILBATH: Seeraga thailam (QUANTITY: 100 ml)

LAXATIVE: Moolakudara thylam – 10-15ml with luke warm water, OD, at early morning in empty stomach

DRUG FORMULATION:

Internal medicine : NILAVAGAI CHOORANAM(BKC)

Dosage : Verukadi alavu (1.375g) Twice a day. After food

Duration : Orumandalam (48 days)

Reference : Brammamuni Karukkidai Choothiram – 380

Author : S. B. Ramachandiran (Editor)

Edition year : February 1998

Page No : 68, 69

Publication : Thamarai Noolagam, 7, N.G.O Colony, Vadapalani, Chennai-26

INCLUSION CRITERIA:

• Age: 18- 60 Years

• Sex: Male, Female, Transgender

• Degree I – III Haemorrhoids

• Patient with Haemorrhoid Symptom Scoring (HSS) ≥ 5

• Patient willing to undergo proctoscopic examination

• Patient willing to give blood samples for the investigations required

• Patient willing to sign informed consent

EXCLUSION CRITERIA:

• Pregnancy and lactation

• Patients with protruding or irreducible haemorrhoids (Grade IV)

• Patients with current history of uncontrolled diabetes mellitus (HbA1c level of >7% to >8%).

• Patients with features of severe hepatic, renal or cardiovascular disorders.

• Patients with any type of anorectal infectious disease.

• Patients presently diagnosed with any anorectal malignancies.

• Fistula in Ano

• Fissure in Ano

• External haemorrhoids

WITHDRAWAL CRITERIA:

• Patient turned unwilling to continuous the course of clinical study

• Poor patient compliance (not taking medicine for more than a week) and defaulters.

• Intolerance to the drug and development of adverse reactions during the study.

OUTCOME OF STUDY

• Improvement of Haemorrhoid Symptom Scoring (HSS)

• Proctoscopic examination –Whether the Pile mass is reduced or not.

RES****ULTS AND DISCUSSION: The results will be statistically analysed and reported

KEYWORDS: moolam, anorectal diseases, NILAVAGAI CHOORANAM, HSS.