CTRI Number |
CTRI/2019/08/020607 [Registered on: 07/08/2019] Trial Registered Prospectively |
Last Modified On: |
06/08/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Jatiphaladi Churna and Chitrakadi Gutika in the treatment of Grahani (Irritable bowel Syndrome) |
Scientific Title of Study
|
Clinical Evaluation of Jatiphaladi Churna and Chitrakadi Gutika in the Management of Grahani |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Purnendu Panda |
Designation |
Research Officer (Ayurveda) |
Affiliation |
Centra Ayurveda Research Institute For Hepatobiliary Disorders, Bharatpur, Bhubaneswar |
Address |
Central Ayurveda Research Institute For Hepatobiliary Disorders, Bharatpur, Bhubaneswar
Khordha ORISSA 751029 India |
Phone |
06742387702 |
Fax |
06742387702 |
Email |
pandapurnendu02@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Purnendu Panda |
Designation |
Research (Ayurveda) |
Affiliation |
Centra Ayurveda Research Institute For Hepatobiliary Disorders, Bharatpur, Bhubaneswar |
Address |
Central Ayurveda Research Institute For Hepatobiliary Disorders, Bharatpur, Bhubaneswar
Khordha ORISSA 751029 India |
Phone |
06742387702 |
Fax |
06742387702 |
Email |
pandapurnendu02@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Purnendu Panda |
Designation |
Research (Ayurveda) |
Affiliation |
Centra Ayurveda Research Institute For Hepatobiliary Disorders, Bharatpur, Bhubaneswar |
Address |
Centra Ayurveda Research Institute For Hepatobiliary Disorders, Bharatpur, Bhubaneswar
Khordha ORISSA 751029 India |
Phone |
06742387702 |
Fax |
06742387702 |
Email |
pandapurnendu02@yahoo.com |
|
Source of Monetary or Material Support
|
Ministry of AYUSH, Govt of INDIA |
|
Primary Sponsor
|
Name |
CCRASNew Delhi |
Address |
Institutional area,Opposite D Block , Janakpuri, New Delhi |
Type of Sponsor |
Other [An autonomous research organisation under ministry of AYUSH] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Purnendu Panda |
CARIHD HOSPITAL Bhubaneswar |
Hospital Division ,Central Ayurveda Research Institute For Hepatobiliary Disorders, Bharatpur
Bhubaneswar Khordha ORISSA |
9777852889 06742387702 pandapurnendu02@yahoo.com |
Dr M N Suryawanshi |
RARIGID HOSPITAL, Guwahati |
Hospital
division,REGIONAL
AYURVEDA
RESEARCH
INSTITUTE FOR
GASTRO-INTESTINAL
DISORDER Borsojai,
Beltola,
Guwahati-781028.
Kamrup
ASSAM Kamrup ASSAM |
8329875011 03612303714 anvay.ojas2006@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Institutional Ethical Committee, CARIHD, Bhubaneswar |
Approved |
Institutional Ethical Committee, RARIGID,Guwahati |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K582||Mixed irritable bowel syndrome, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
1. Jatiphaladi Churna
|
Dose: 2gm twice daily
Dosage form: Churna (powder)
Route of Administration : Oral
Time of Administration : Twice a day after food
Anupana : Water
Duration of therapy 12 weeks
|
Intervention |
2.Chitrakadi Gutika |
2.Dose: 500mg (one tab) twice daily
Dosage form Vati (Pill/Tablet)
Route of Administration : Oral
Time of Administration : Twice a day after food
Anupana : Water
Duration of therapy: 12 weeks
|
Comparator Agent |
Not Applicable |
Nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Patients of either sex aged 18-65 years
2. Known cases of Grahani (diagnostic criteria as per classical Ayurvedic Parameters) with following symptoms
3. Patients willing to give written informed consent and able to participate for 3 months.
|
|
ExclusionCriteria |
Details |
1. Patients with history of Inflammatory Bowel Disease (IBD), Koch’s Abdomen, Gluten Intolerance.
2. Patients with history of chronic amoebiasis.
3. Known cases of Diabetes Mellitus.
4. Patients with poorly controlled Hypertension ( >160/100 mmHg)
5. Patients who have history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months
6. Symptomatic patients with clinical evidence of Heart failure
7. Known cases of malignancy
8. Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease (COPD).
9. Women who are planning for conception / pregnant or lactating.
10. H/o hypersensitivity to any of the trial drugs or their ingredients
11. Patients who have completed participation in any other clinical trial during the past three months
12. Any other condition which the Investigator thinks may jeopardize the study
|
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
|
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To assess the clinical efficacy of Jatiphaladya Churna & Chitrakadi Gutika by the assessment of Changes in Ayurvedic Parameters of Grahani
|
Base line , At the end of 14th day, 28th day, 42nd day, 56th day, and 70th day, 84th day and 98th day.
|
|
Secondary Outcome
|
Outcome |
TimePoints |
To assess the clinical efficacy of Jatiphaladya Churna & Chitrakadi Gutika by the assessment of Changes in IBS-QOL score |
Base line , At the end of 14th day, 28th day, 42nd day, 56th day, and 70th day, 84th day and 98th 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 2/ Phase 3 |
Date of First Enrollment (India)
|
21/08/2019 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
According to
Ayurveda “Rogaah Sarvepimandagou†means all the diseases are caused by mandagin
((digestive fire or various enzymatic process involved in digestion,
absorption and metabolism at various level) which causes improper digestion of
ingested nutrients (food) leading to formation or accumulation of Amadosha
(intermediate products/or toxins) which produces its effect locally or
generalized) .Grahani (middle part of amasaya and pakwasaya) is the place of
Jatharagin. When the digestive power of grahani became less due to the improper
food habits and stressfull life style. It causes Grahani roga which is known as
Grahani in Ayurveda. In general, the digestion and absorption of food materials
can be divided into 3 major phases: Luminal, Mucosal and Post - absorptive
phases. The luminal phase in which di fats, proteins, and carbohydrates are
hydrolyzed and solubilised by secreted digestive enzymes and bile can be
considered to be the role of Pachaka Pitta which is responsible for the
breakdown and synthesis of substances i.e. catabolic and anabolic activities.
Mucosal phase relies on the integrity of the brush-border membrane of
intestinal epithelial cells to transport digested products from the lumen into
the cells is compared to Kledaka Kapha by
the virtue of its cooling property which
counter the heating property of Pitta. In modern medicine, the disease can be co-related
with malabsorption syndrome and also Irritable Bowel Syndrome. There are
enormous formulations mentioned in Ayurvedic classics for the augmentation and
restoration of Agnibala in general and Grahani in particular.Jatiphaladya
Churna & Chitrakadi gutika are reputed formula, though mentioned in the
Sarangadhara Samhita and Charaka Samhita respectively in Ayrveda classics, for the
treatment of Grahani, Atisara, Agnimandya etc.
As
grahani roga is caused due to agnimandya, the main line of treatment is to
correct the agnidusti by administering drugs which are deepana and pachana in
action. The trial durgs like Jatiphaladi Churna and Chitrakadi Gutika are classical medicines formulated by Achary
Charak and Acharya Sarangadhara.Which are referred to AFI,Part-I, 7:12. and
AFI,Part-I, 12:11. The Ingredients which these trial medicines are contains, having properties like deepan,
pachana and sthambhaka and can able to correct the agnimandya condition and
disordered of purishavaha stoats.
So the aim and object of the present study is
planned to evaluate therapeutic efficacy of Jatiphaladi Churna and Chitrakadi
Gutika in the patients of Grahani along with safety measures by observing
adverse events (AE) if any or Adverse drug reaction (ADR). The efficacy of
these drugs would be assessed by observing the improvement in Subjective
parameters (Clinical Symptoms). Improvement in WHOQOL score and lab parameters.
|