| CTRI Number |
CTRI/2023/05/052298 [Registered on: 04/05/2023] Trial Registered Prospectively |
| Last Modified On: |
03/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of impaired digestive /Ama on feces and role of Chitrakadi Vati as of its correction |
|
Scientific Title of Study
|
Association between symptoms of Ama and Purisha characteristics features and evaluation of Chitrakadi tablet as Amapachana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suresh Panchal |
| Designation |
MD Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Roga Nidan Evam Vikriti Vigyan 5th floor ITRA Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9662963329 |
| Fax |
|
| Email |
suryapanchal1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D H Pandya |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Roga Nidan evam Vikriti Vigyan Fifth floor Room no 515 Institute
building ITRA Jamnagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9099011095 |
| Fax |
|
| Email |
darshnapandya73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D H Pandya |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Roga Nidan evam Vikriti Vigyan Fifth floor Room no 515 Institute
building ITRA Jamnagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9099011095 |
| Fax |
|
| Email |
darshnapandya73@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Opposite Reliance smart ITRA Jamnagar |
| 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 |
| Suresh Panchal |
PG Hospital Institute of Teaching and Research in Ayurveda |
OPD No 16 PG
Hospital Roga Nidan evam Vikriti Vigyan
Institute of Teaching
and Research in
Ayurveda
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
9662963329
suryapanchal1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Institute of Teaching and Research in Ayurveda Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: AMADOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chitrakadi Vati, Reference: Charak samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 to 50 years
Patient having at least three symptoms of Ama i.e., Udara Gaurava (heaviness in abdomen),
Mala Sanga (retention of feces/constipation)), Apakti (indigestion).
Willing to participate and abide to study protocol |
|
| ExclusionCriteria |
| Details |
Patient below 18 years and above 50 years of age.
Not willing to participate.
Patient who is already on ayurveda medication especially for Pachana
Chronic debilitating disease like CA, DM, T.B, CKD.
Ulcerative colitis, peptic ulcer and haemorrhoids, cirrhosis of liver,
portal hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subsidence generalized defecation related symptoms of Ama |
day 0 and 16th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Absence of stickiness from feces
The stool remains float over water (Jala Santarana)
|
Day 0 and 16th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/05/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
It is a Survey and clinical study to establish Association between symptoms of Ama and Purish characteristic features (if any) and evaluation of Chitrakadi tablet as Amapachana. As per Ayurveda concept disease are having symptoms of Ama in initial stage, impact of Ama reflects on feces quality of the patients too. To observe these characteristics. Patient having at least three symptoms of Ama i.e., Udara Gaurava (heaviness in abdomen), Mala Sanga (retention of feces/constipation)), Apakti (indigestion) and age between 18 to 50 years.In this study total 100 patients will be registered. After taking their inform consent recruited subjects will be analysed for presence of Ama and other examinations on the basis of prepared Performa. One day 0 the subject will be undergone for blood test Hb, CBC, ESR, FBS, Lipid profile, Renal function test and Urine routine and microscopic examination, stool microscopic examination. Further feces examination for its characteristics feature in context of Ama will also be assessed. Out of surveyed patients who are willing to participate and abide to study protocol will be recruited for clinical trial. These patients will be given Chitrakadi tablet 2 tab. Twice a day after meal with luke warm water for 15 days. Patient will be assessed weekly for their impact in symptoms of Ama at the end of 15days, the patients will undergo for stool examination again (physical, microscopic & Jala Nimanjjan and other characteristics features of stool).Subjects will be assessed on the basis of especially prepared proforma incorporating demographic data, symptoms of Ama and details about Mala Parikshana. A closed ended questionnaire will be used to analyse Purishvaha Srotas dushti Lakshana and Sama Mala Lakshana. Written informed consent from subjects will be taken prior to registering them for the study |