| CTRI Number |
CTRI/2019/01/017047 [Registered on: 11/01/2019] Trial Registered Prospectively |
| Last Modified On: |
09/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study on effect of alkaline preparation of two species of chiraita processed in Buffalo urine in loss of digestive power. |
|
Scientific Title of Study
|
Comparative clinical study on kshar of Swertia chirayata roxb. Flem. and Swertia angustifolia buch-ham.Exd.Don,processed in mahish mootra w.s.r.to agnideepan activity. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohan lal Jaiswal |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Dravyaguna, National Institute of Ayurveda, Jorawar Singh Gate, Amer road, Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414778431 |
| Fax |
|
| Email |
polospirit2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sabita Sapkota |
| Designation |
PG scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Dravyaguna, National Institute of Ayurveda, Jorawar Singh Gate, Amer road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
09587112737 |
| Fax |
|
| Email |
sapkotasabita1988@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabita Sapkota |
| Designation |
PG scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Dravyaguna, National Institute of Ayurveda, Jorawar Singh Gate, Amer road, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
09587112737 |
| Fax |
|
| Email |
sapkotasabita1988@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda,Jorawar Singh Gate,Amer Road,Jaipur,Rajasthan,302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar Singh gate, Amer road, Jaipur, Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 Sabita Sapkota |
National Institute of Ayurveda |
Room no-19,Department of Dravyaguna
Jaipur
RAJASTHAN |
9587112737
sapkotasabita1988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kshar of Swertia angustifolia . |
Kshar of Swertia angustifolia 1gm/day in two divided doses will be given orally for 21 days with 3gm melted ghee.
|
| Comparator Agent |
Kshar of Swertia chirayata. |
Kshar of Swertia chirayata 1gm/day in two divided doses will be given orally for 21 days with 3gm melted ghee. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having classical signs and symptoms of jatharagnimandhya like Avipaka, Chardi, Angamard, Udara Gaurav, Ksudhanasa, Mukha durgandha, etc will be selected.
2.Patients of either sex with age group between 20 to 70 years will be selected. |
|
| ExclusionCriteria |
| Details |
Patients with chronic disease like severe Hypertension, IHD, COPD, DM, cancer, Hepatic and renal insufficiency, psychotic disorders like depression, schizophrenia.
2.Any acute illness /serious illness.
3.Pregnant women and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective and objective parameters. |
21days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find comparative efficacy of either treatment. |
21 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/01/2019 |
| 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="0"
Months="0"
Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ayurveda views the health of an individual as the proper functioning of Agni(digestive fire inside body). Agnimandhya is the pathological state of inhibited agni.As per Acharya Baghbhat Agnimandhya leads to manifestation of all types of diseases. Kshar is prescribed to cure Agnimandhya . Acharya Charak has described Bhunimbadi kshar to cure Agnimandhya. In this study kshar of two species of chiraita (bhunimb) i. e Swertia chirayata and Swertia angustifolia are taken. The study aims to compare the effectiveness of both drugs. |