| CTRI Number |
CTRI/2024/09/073407 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Diagnostic Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinial study to find the effect of two ayurvedic drugs drakshadi gutika and simhasyadi ghana vati in two groups of patients with functional dyspepsia |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF SIMHASYADI GHANA VATI IN THE MANAGEMENT OF FUNCTIONAL DYSPEPSIA (AMLAPITTA) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sindhana U |
| Designation |
P G Scholar Dept of Kayachikitsa SJSACH |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Department of Kayachikitsa Room no 17 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Poonamallee Chennai
Thiruvallur TAMIL NADU 600123 India |
| Phone |
7598497325 |
| Fax |
|
| Email |
sindhana25@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vipin S G |
| Designation |
Associate Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Department of Kayachikitsa Room no 17 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Poonamallee Chennai
Thiruvallur TAMIL NADU 600123 India |
| Phone |
8547626217 |
| Fax |
|
| Email |
drvipinsg@sjsach.org.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Vipin S G |
| Designation |
Associate Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Department of Kayachikitsa Room no 17 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Poonamallee Chennai
Thiruvallur TAMIL NADU 600123 India |
| Phone |
8547626217 |
| Fax |
|
| Email |
drvipinsg@sjsach.org.in |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet chennai-600123 |
|
|
Primary Sponsor
|
| Name |
Sindhana U |
| Address |
Department of Kayachikitsa Room noc17 Sri Jayendra Saraswathi Ayurveda college and Hospital Nazarathpet Poonamallee Chennai 600123 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sindhana U |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Dept of Kayachikitsa Room no 17 Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Poonamallee Chennai Thiruvallur TAMIL NADU |
7598497325
sindhana25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri jayendra saraswathi ayurveda college and hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Simhasyadi ghana vati, Reference: chakradatta, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Drakshadi ghana vati, Reference: Ashtanga hridayam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient fullfilling the diagnostic criteria.
2.Participants from whom the written consent is obtained. |
|
| ExclusionCriteria |
| Details |
1.K/C/O Peptic ulcer or any organic lesions and other systemic disorders.
2.Patients under NSAID s ,antibiotics or other long term and continuous medications.
3.History of Hematemesis.
4.Unintentional weight loss 5kg within 6months.
5.History of smoking and alcohol addiction.
6.Symptoms such as recurrent vomitting,bleeding through rectum,malena,anemia,dysphagia.palpable mass per abdomen.
7.Pregnant women and lactating mother. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of signs and symptoms of Functional dyspepsia |
Reduction of signs and symptoms of Functional dyspepsia within 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
16/09/2024 |
| 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="1" 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
|
The
classical reference of Amlapitta are from Kashyapa Samhita ,Yogaratnakara
and Bhava-prakasha and Madhav Nidana,.In Amlapitta the
root cause is Agnimandya and formation of Aama .Treatment of Amlapitta : Agnideepaka and Aamapachaka
drugs are used .Tikta Rasapradhana drugs are commonly Aamapachaka
& Agnideepaka acts on
annavaha srotas. All diseases are
caused by Mandagni (weak digestive fire), which negatively affects the samana
and udana vayu, as both vayu are responsible for proper digestion.The
excessive consumption of Amla (sour), Katu (spicy), Ushna
(hot), and Viruddhashana (incompatible food combinations) can lead to an
aggravation of Pitta dosha. Normally, Pitta has a Katu rasa
(spicy taste), but when it is converted into Amla rasa (sour taste), it
results in Amlapittam. Diagnosis is done based on Rome IV criteria.
Trial
drug : Simhasyadi ghana vati told in Chakradatta / Amlapitta adhikara.The ingredients are Vasa(Adatoda vasica ), Guduchi(Tinospora
cardifolia ) and Brihati (Solanum indicum). It is indicated in Amlapitta,svasa,kasa
and chardi expected to have effectiveness in Functional
dyspepsia (Amlapitta). The mode of action of this yogam is Pittashamaka
and Tridoshagna property due to its kashaya rasa , madura vipaka , laghu
, snigha guna ,ushna veerya. It contains chemical constituents such as
pyrroloquinazoline , glucosides which helps in healing the gastric mucosa. |