| CTRI Number |
CTRI/2024/06/069131 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to evaluate the therapeutic effectiveness of selective Siddha Medicines – VeBSaM Therapy in the management of Cholelithiasis |
|
Scientific Title of Study
|
An Open clinical trial to evaluate the therapeutic effectiveness of selective Siddha Medicines - VeBSaM Therapy in the management of Cholelithiasis |
| 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 NISHA K J |
| 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 |
9965360794 |
| Fax |
|
| Email |
nishajageerushan@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, Chennai
Chennai
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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr NISHA K J |
Ayothidoss Pandithar Hospital |
Room no 7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47
Chennai
TAMIL NADU |
9965360794
nishajageerushan@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vengara parpam, Bavana panjangula thailam, Santha santhrothayam, Manjal noi kudineer |
Vengara Parpam - 100 mg Bd With Ghee,
Bavana Panjangula Thailam - 4 ml Bd With Milk,
Santha Santhrothayam - 2 Bd With Honey,
Manjal noi kudineer - 5grams Bd made into Decoction.
For 90 Days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants who were diagnosed Cholelithiasis by ultrasound scanning – size of the gallbladder stone between 3 to 10 mm. |
|
| ExclusionCriteria |
| Details |
1.Participants with comorbidities like renal failure and liver cirrhosis
2.Pregnant and lactating mother.
3.Severe Cholecystitis, Choledocholithiasis, Acute and Chronic Pancreatitis.
4.Participants with Gallstone present in neck of gall bladder.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the size of stone will be assessed by ultra sonogram before and after treatment |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Scoring Difference will be assessed in OTAGO Gallstones condition specific questionnaire in cholelithiasis participants before and after taking siddha treatment |
6 MONTHS |
|
|
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)
|
23/06/2024 |
| 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 medicine is an ancient systems of medicine which
contributes in treating the disease as well as plays an important role in revitalizing
and rejuvenating the mind and body. Generally 4448 types of diseases are
classified in the siddha system. This classification is mainly based on the
derangement of 3 major humors, Vatham, Pitham and Kabam. Gall bladder (Pitha
pai) is an organ which is existing in Pithasthanam in our body.
Gallstone disease is caused by derangement of Pitham humor.
Gallstones are formed from the constituents of the bile (cholesterol,
bile pigments and calcium salts) along with other organic components. They are
usually formed in gallbladder, but sometimes develop within extrahepatic biliary
passages, and rarely in the larger intrahepatic bile duct. In India, the prevalence
of gall stones is about 10-15% in adults[2]. The incidence of gall stones varies
markedly in different geographic areas, age, gender, diet and various other risk
factors. Gallstones are common in 4Fs acronym for – Fat, Female,
Fertile(multipara) and Forty. Gallstone in one among the lifestyle related diseases
caused by the recent change in the dietary pattern.
There is an increased number of patients affected by Cholelithiasis,
reporting at the OPD. This trial may provide alternate option for participants since
surgery is the most suggested intervention in modern medicine. Most of the trial
drug contains Hepatoprotective, hypolipidemic, antioxidant, Lithotriptic activity
as mentioned in various research articles. Hence I had chosen this formulation
“Vengara parpam, Bavana panjangula thailam, Santha Santhrothayam, Manjal
noi kudineer†for the management of Cholelithiasis.
OBJECTIVE: To evaluate the therapeutic effectiveness of selective Siddha medicines - Vengara parpam, Bavana panjangula thailam, Santha Santhrothayam, Manjal noi kudineer in the management of Cholelithiasis by reduction
in size of the stone will be measured.
METHODOLOGY: 20 diagnosed patients of Cholelithiasis within the age limit of 20-60 years willing to paticipate in the study by signing the consent form will be enrolled in the study based on the inclusion criteria and exclusion criteria.
OUTCOME: Reduction in size of stone will be assessed by using ultrasonogram before and
after taking siddha treatment.
Scoring Difference will be assessed in OTAGO Gallstones condition specific
questionnaire in the cholelithiasis participants before and after taking siddha treatment.
RESULTS AND DISCUSSION: The results will be statistically analysed and reported.
KEYWORDS: Cholelithiasis, Pithapai kal, Vengara parpam, Bavana panjangula thailam, Santha Santhrothayam, Manjal noi kudineer. |