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CTRI Number  CTRI/2024/04/066321 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 23/04/2024
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 Nilavagai Chooranam(BKC) in the treatment of Moolam(Internal Hemorrhoids) 
Scientific Title of Study   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 
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 Venkatesh S 
Designation  PG Scholar 
Affiliation  National Institute Of Siddha 
Address  Room no 7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium

Chennai
TAMIL NADU
600047
India 
Phone  9659418223  
Fax    
Email  venkatesh.spkv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr T Lakshmikantham 
Designation  Associate Professor and Head of the Department(I/C) 
Affiliation  National Institute of Siddha 
Address  Room no 7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium

Chennai
TAMIL NADU
600047
India 
Phone  9025575185  
Fax    
Email  drlakshmiramaswamy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr T Lakshmikantham 
Designation  Associate Professor and Head of the Department(I/C) 
Affiliation  National Institute of Siddha 
Address  Room no 7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium


TAMIL NADU
600047
India 
Phone  9025575185  
Fax    
Email  drlakshmiramaswamy@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 
Dr Venkatesh S   Ayothidoss Pandithar Hospital   Room no 7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47
Chennai
TAMIL NADU 
9659418223

venkatesh.spkv@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: K649||Unspecified hemorrhoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nilavagai Chooranam(BKC)  A compound herbal drug powder indicated to treat various anorectal conditions advised to intake 3grams for 48days by text 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Degree I – III Haemorrhoids
Patient with Haemorrhoid Symptom Scoring (HSS) greater than or equal to 5
Patient willing to undergo proctoscopic examination
Patient willing to give blood samples for the investigations required
Patient willing to sign informed consent  
 
ExclusionCriteria 
Details  Pregnancy and lactation
Patients with protruding or irreducible haemorrhoids Grade IV
Patients with current history of uncontrolled diabetes mellitus HbA1c level of greater than 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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement of Haemorrhoid Symptom Scoring (HSS);
Proctoscopic examination –Whether the Pile mass is reduced or not.
 
48days 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   19/06/2024 
Date of Study Completion (India) 01/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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:
  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.

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

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

 
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