| CTRI Number |
CTRI/2023/09/057631 [Registered on: 14/09/2023] Trial Registered Prospectively |
| Last Modified On: |
13/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Evaluate The Effectiveness Of Sarapanga Vilvathy Legiyam In The Treatment Of Acid Peptic Disease (Eri gunmam) |
|
Scientific Title of Study
|
A Pilot Study To Evaluate The Effectiveness Of Sarapanga Vilvathy Legiyam In The Treatment Of Acid Peptic Disease (Erigunmam) |
| 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 Siva Lakshmi S |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of siddha |
| Address |
Department of Maruthuvam
National Institute of siddha
Tambaram sanatorium
Chennai-45
Kancheepuram
TAMIL NADU
600045
India |
| Phone |
04422411611 |
| Fax |
|
| Email |
sslaxmimbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siva Lakshmi S |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of siddha |
| Address |
Department of Maruthuvam
National Institute of siddha
Tambaram sanatorium
Chennai-45
TAMIL NADU
600045
India |
| Phone |
04422411611 |
| Fax |
|
| Email |
sslaxmimbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siva Lakshmi S |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of siddha |
| Address |
Department of Maruthuvam
National Institute of siddha
Tambaram sanatorium
Chennai-45
TAMIL NADU
600045
India |
| Phone |
04422411611 |
| Fax |
|
| Email |
sslaxmimbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Chennai-47 |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 Siva Lakshmi S |
Ayothidoss pandithar hospital,National Institute of siddha |
Room Number 7,
Department of Maruthuvam,
Tambaram Sanatorium
Chennai 47
Kancheepuram
TAMIL NADU |
9445245372
sslaxmimbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee National Institute of Siddha Tambaram sanatorium Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Sarapanga Vilvathy legiyam |
Dosage : 1 ¼ varagan (5 g) twice a day before food
Duration of treatment : 90 days
Indication : Gunmam 8, Kirani 6, Vellokkalam, Vaikasappu, Vaineerooral, Vayirumantham, Soolai, kai kaal kaanthal, Pitham 40
Reference : Siddha vaidhya Thirattu
PageNumber : 334
Edition : 8th edition (2021)
Publishedby : Directorate of Indian medicine and homeopathy
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with the symptoms of epigastric abdominal pain, Heart burn with or without regurgitation, abdominal bloating, nausea, vomiting, belching, hematemesis (Any 3 or 4)
2.Willing to take endoscopy before and after the trial period.
3.Willing to give blood specimen for the investigation when required.
4.Patient who are willing to sign informed consent form.
|
|
| ExclusionCriteria |
| Details |
1.k/c/o Diabetes mellitus
2.k/c/o Hypertension
3.k/c/o Cardiac ailments
4.Known Cases of Acute Abdomen (Appendicitis, Pancreatitis, Cholecystitis)
5.k/c/o Hiatus hernia
6.k/c/o Gastric/ Esophageal Carcinoma
7.k/c/o Liver cirrhosis
8.Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome assessed by comparing the reduction of clinical symptoms before & after treatment by using Gastro-intestinal symptoms rating scale (GSRS).
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is assessed by comparing the Endoscopic results before & after treatment for 20 percentage of selected patients. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
23/09/2023 |
| 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)
|
Open to Recruitment |
| 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
|
Acid
Peptic Diseases (APD) includes GERD, Peptic ulcer diseases(PUD). APD is the
common condition reported in daily practice and which is due to the hyper
acidity or reduced mucosal protection. Globally,
the number of prevalent cases of GERD increased by 77.53% from 441.57 million
(95% UI 383.48– 496.84) in 1990 to 783.95
million (689.55–876.53) in 2019 and in worldwide PUD affects four million
people annually. Clinical presentation of patients with
GERD and PUD are Heart burn with regurgitation or without regurgitation,
epigastric abdominal pain,abdominal bloating, nausea, vomiting, Sleep
disturbances, Pain awakening at night, weight loss, GI bleeding, anemia, melena.
In Siddha, According
to "Yugi vaithya sinthamani", Gunmam is classified into eight types. In
which Eri Gunmam is one among them. The signs and symptoms of this disease are
correlated with Acid Peptic disorder in modern science. In
the Siddha vaidhya thirattu text book, Sarapanga vilvathy legiyam is specially
indicated for Envagai gunmam (Acid peptic disease), Vellokkalam (Nausea),
Vaikasappu (Bitter taste in tongue), Vaineerooral (Increased salivation),
Vayiru mantham (Indigestion). These are all very much related to Acid peptic
disease.
Sarapanga
vilvathy legiyam is a herbal
medicine having 38 ingredients. Out of which, 16 main drugs are roots which have
proven activities of anti ulcer,
anti-secretory and cytoprotective. i.e.vilvaver kattai (root of Aegle
marmelos.L) have proven anti-ulcer activity(5). Mutkavelai ver
(Root of Tephrosia purpurea.L) have proven anti-ulcer activity(6)
Saaranaiver (root of Trianthem adecandra.L) have proven antiulcer, anti-secretory
and cytoprotective effects(7) Sangam ver (root of Azema tetracantha.L) have proven Anti-ulcer
activity(8).
So
the aim of this treatment with sarapanga vilvathy legiyam includes relief of
symptoms, enhancement of ulcer healing in the affected mucosa and prevention of
recurrence.This formulation has not undergone any clinical trial for this
condition so far.
|