| CTRI Number |
CTRI/2023/02/049708 [Registered on: 14/02/2023] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the effectiveness of Pancha Deepakini Chooranam for moolam ( haemorrhoids) |
|
Scientific Title of Study
|
AN OPEN , CLINICAL TRIAL TO EVALUATE THE EFFECTIVENESS OF SIDDHA HERBAL
FORMULATION PANCHA DEEPAKINI CHOORANAM IN THE TREATMENT OF MOOLAM
( HAEMORRHOIDS) IN PATIENTS ATTENDING AYOTHIDOSS PANDITHAR HOSPITAL ,
NATIONAL INSTITUTE OF SIDDHA, CHENNAI |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Niraimathi |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9787569186 |
| Fax |
|
| Email |
niraimathi431597@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Nalini Sofia |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Room no 7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
|
| Email |
drhnalinisofia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Niraimathi |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9787569186 |
| Fax |
|
| Email |
niraimathi431597@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
Kancheepuram
Chennai 600047 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Niraimathi |
National Institute of Siddha |
Room no 7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Kancheepuram
Chennai 600047
Kancheepuram
TAMIL NADU |
9787569186
niraimathi431597@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Sidddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Pancha Deepakini Chooranam |
1gms bd with ghee for 48 days |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults who are diagnosed with hemorrhoids are included in the study .
2. Grade I – III haemorrhoids examined by proctoscope , with complaints of bleeding per
rectum, anal pain, discharge, itching,mass in the anal canal.
3.Patient willing to undergo proctoscopic examination.
4.Patient willing to sign informed consent |
|
| ExclusionCriteria |
| Details |
1.Pregnancy and lactation.
2. Uncontrolled diabetes mellitus.
3. Patients with any type of infectious disease.
4. Patients presently diagnosed with cancer. 5.Fistula in Ano .
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement of Haemorrhoid Symptom Scoring (HSS)
Proctoscopic examination - Any reduction in the size of the pile mass will be assessed through proctoscopic examination. |
1month - SCREENING
2months - PATIENT ENROLLMENT
1month - OUTCOME ASSESSMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/02/2023 |
| Date of Study Completion (India) |
29/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION: This is a clinical trial that evaluates the effectiveness of siddha formulations PANCHA DEEPAKINI CHOORANAM in the treatment of moolam ( haemorrhoids ) patients through haemorrhoid symptom scoring (HSS). Haemorrhoids arise from congestion of the internal and/or external venous plexuses around the anal canal. They are extremely common in adults. The aetiology is unknown, although they are associated with constipation and straining and may develop for the first time during pregnancy. First – degree piles bleed, while second – degree piles prolapsed but retract spontaneously. Third – degree piles are those which require manual replacement after prolapsing. Bright red rectal bleeding occurs after defecation. Other symptoms include pain, pruritus ani and mucous discharge.The word “haemorrhoid†is derived from the Greek word ‘haema’ (blood) and ‘rhoos’ (flowing) and it was probably Buqrat who was the first to apply this name to the flow of blood from the veins of the anus. The term ‘piles’ is derived from the latin word ‘pila’ (a ball) and was widely used by the public. Haemorrhoid is a common disease with a prevalence of 4.4 % with a peak occurring in both sexes between 45 -65 years. The frequency of the disease in india is 32 – 40 % but exact data of its prevalence is rare.
OBJECTIVE: To Evaluate the effectiveness of siddha herbal formulation PANCHA DEEPAKINI CHOORANAM in the treatment of MOOLAM patients through proctoscopy and haemorrhoid symptom scoring (HSS).
MATERIALS AND METHODS: A total of 10 diagnosed adult patients willing to particupate in the study , by signing the consent form will be enrolled in the study . Having uncontrolled diabetes mellitus, any type of infectious disease,diagnosed with cancer,Fistula in Ano will be excluded from the study. Assesssment will be done haemorrhoid symptom scoring (HSS) pre and post treatment.
RESULTS AND DISCUSSION: The results will be statistically analysed.
KEYWORDS: Pancha deepakini chooranam ,moolam, haemorrhoids |