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CTRI Number  CTRI/2024/06/069199 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 14/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   A study on Siddha formulation Gowri Chinthamani Chendooram for Moolam [Haemorrhoids] 
Scientific Title of Study   An Interventional Study to evaluate the effectiveness of Siddha formulation Gowri Chinthamani Chendooram along with Siddha line of treatment Seeraga thylam oilbath and Moolakudara thylam laxative in the treatment of Moolam (Haemorrhoids) among Out-patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennnai-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 Abirami S 
Designation  Pg scholar 
Affiliation  National Institute of Siddha 
Address  Room no 7/8, Department of Maruthuvam, National Institute of Siddha,Tambaram Sanatorium Chennai.

Chennai
TAMIL NADU
600047
India 
Phone  9597350346  
Fax    
Email  abiramisammu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr H Vetha Merlin Kumari 
Designation  Associate Professor 
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  9894782366  
Fax    
Email  dr.vetha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr H Vetha Merlin Kumari 
Designation  Associate Professor 
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  9894782366  
Fax    
Email  dr.vetha@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 Abirami S  Ayothidoss Pandithar Hospital  Room no7/8,Department of Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Chennai-47.
Chennai
TAMIL NADU 
9597350346

abiramisammu@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: K641||Second degree hemorrhoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gowri chinthamani chendooram  200 mg of Gowri Chinthamani Chendooram along with Adjuvant 1.375 g (Kattukarunaikilangu podi+ kadukkai podi +sukku podi + thippili podi) with honey Bd, after food for 48 days 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Degree I – II Haemorrhoids
2. Participants with Haemorrhoid Symptom Scoring (HSS) ≥ 5
3. Participants willing to undergo proctoscopic examination
4. Participants willing to give blood samples for the investigations required

 
 
ExclusionCriteria 
Details  1.Pregnancy and lactation.
2.Fistula in Ano
3.Fissure in Ano
4.External haemorrhoids
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement of Haemorrhoid Symptom Scoring (HSS) after treatment.
Reduction in the size of the Pile mass in Proctoscopic examination after treatment.
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 traditional systems of medicine in India. The uniqueness of siddha system is evident by its continuous service to the mankind in combating diseases and also in maintaining its physical, mental and moral health. The diagnosis of disease in siddha system of medicine relies on eight diagnostic tools called Ennvagai Thervu such as Naadi, Sparisam, Naa, Niram, Mozhi, Vizhi, Malam, Moothiram which are evaluated in terms of three humors. Saint Agasthiyar identified 4448 diseases and one among them is Eruvai Mulai noi. Any derangements in humors results in development of diseases. Yugi mentioned the disease Moolam and its types in Yugi Vaithiya Chinthamani. This disease is mainly due to aggravated vatham and pitha humors. In Moola noi, deranged Vatha humor triggers 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. As per Siddha, Siddhars notify Moolatharam is a seat of Kundalini Sakthi (Energy point). Any irregular practice of yoga, food and lifestyle modifications may disturb the moolatharam and results in disease called Moolam. Haemorrhoids are a very common anorectal condition and is formed by a dilatation of veins in the external and internal haemorrhoidal plexuses. Clinically there are two types of Haemorrhoids viz. Internal Haemorrhoids and External Haemorrhoids. Based upon the protrusion of mass, it’s subdivided into 4 grades. 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 haemorrhoidal 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 1and 2. Conditions Refractory to conservative management or stage 3 and 4 Hemorrhoids 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 formulation GOWRI CHINTHAMANI CHENDOORAM in the treatment of MOOLAM ( FIRST AND SECOND DEGREE HAEMORRHOIDS) among Haemorrhoids patients through   proctoscopy and Haemorrhoid symptom scoring (HSS) before and after treatment.

 

STUDY DESIGN: This is an interventional study of Non randomized sampling which will  be carried out for 6 months in patients with haemorrhoids reporting at OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennai – 600 047 with 20 patients as sample size. Patients with Age ≥ 18 years and ≤ 60 years of Both sex, and Participants  with First and second degree Haemorrhoids,

Participants with Haemorrhoid Symptom Scoring (HSS) ≥ 5, Participants willing to undergo proctoscopic examination, Participants willing to give blood samples for the investigations required will be included in this study. Patients with fissure in ano, fistula in ano, external haemorrhoids and pregnant and lactating women will be excluded from the study.

 OUTCOME OF STUDY

                        Improvement of Haemorrhoid Symptom Scoring (HSS) after treatment.

                        Reduction in the size of the Pile mass in Proctoscopic examination after treatment

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

KEYWORDS: moolam, anorectal diseases, Gowri chinthamani chendooram.

 

 

 

 

 
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