| CTRI Number |
CTRI/2019/03/018112 [Registered on: 15/03/2019] Trial Registered Prospectively |
| Last Modified On: |
19/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Guduchyadi Karma Basti (enema) and Rasayana Avaleha used for treatment of Cancer |
|
Scientific Title of Study
|
An interventional comparative clinical study on Guduchyadi Karma Basti and Rasayana Avaleha in the management of Cancer W.S.R. Gastro-intestinal cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
amit awadhiya |
| Designation |
m.d. scholar |
| Affiliation |
IPGT & RA GAU jamnagar gujarat india |
| Address |
4th floor panchkarma department IPGT & RA GAU jamnagar gujarat india
Jamnagar
GUJARAT
361008
India |
| Phone |
9713995463 |
| Fax |
|
| Email |
amitawadhiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANUP THAKAR |
| Designation |
director and HOD |
| Affiliation |
IPGT and RA jamnagar gujarat |
| Address |
4th floor panchkarma department IPGT & RA GAU jamnagar gujarat india
panchkarma department IPGT &RA jamnagar gujarat india
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANUP THAKAR |
| Designation |
director and HOD |
| Affiliation |
IPGT and RA jamnagar gujarat |
| Address |
4th floor panchkarma department IPGT & RA GAU jamnagar gujarat india
panchkarma department IPGT &RA jamnagar gujarat india
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| IPGT & RA GAU JAMNAGAR GUJARAT |
|
|
Primary Sponsor
|
| Name |
IPGT and RA GAU jamnagar |
| Address |
GUJARAT AYURVED UNIVERSITY
JAMNAGAR GUJARAT |
| 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 |
| Amit Kumar Awadhiya |
IPGT and RA GAU, JAMNAGAR |
OPD no. 14 panchkarma department
Jamnagar
GUJARAT |
9713995463
amitawadhiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee IPGT & RA GAU JAMNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D498||Neoplasm of unspecified behavior of other specified sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guduchyadi karma Basti |
Guduchyadi karma Basti combination of Guduchi grita anuvasana basti 100 to 120 ml and guduchyadi niruha basti 600 to 800 mal for 30 days in gastro intestinal cancer |
| Intervention |
Guduchyadi karma Basti along with rasayana Avaleha |
Guduchyadi karma Basti combination of Guduchi grita anuvasana basti 100 to 120 ml and guduchyadi niruha basti 600 to 800 mal for 30 days along with rasayana avaleha30gm per day for 30 days in gastro intestinal canc |
| Comparator Agent |
modern cancer treatment |
palliative conservative medicine for cancer treatment or in follow up in cancer treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with histopathologically proved diagnosed as 1st and 2nd stage of Gastro-intestinal Cancer
From oral cavity to large intestine
Patients who are suitable for Basti Karma
Willing and able to participate in the study |
|
| ExclusionCriteria |
| Details |
Patients diagnosed as 3rd and 4th stage of cancer of any type
Chronic long term local adverse effects.
Known cases of hypertension or ischemic heart disease and acute infection etc
Patients with ano-rectal carcinoma
Cachexic or terminally ill patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy |
prospective |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety |
prospective |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2019 |
| Date of Study Completion (India) |
03/06/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
submit to Ayu journal for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is An randomized Interventional Comparative Clinical trial to evaluate the effect of Guduchyadi Karma Basti and Rasayana Avaleha in the Management of Cancer w.s.r. Gastro-intestinal Cancer. total 30patients will be enrolled in present study. Selected patients will be divided in three group on the basis of computer generated randomisation. in this study in group A Guduchyadi Karma Basti which is combination of Guduchi Ghrita Anuvasana Basti(100ml to 120ml ) and Guduchyadi Niruha Basti(600ml to 900ml) will be given though rectal route for 30 day in alternate day pattern and in group B Guduchyadi Karma Basti which is combination of Guduchi Ghrita Anuvasana Basti(100ml to 120ml ) and Guduchyadi Niruha Basti(600ml to 900ml) will be given though rectal route for 30 day in alternate day pattern with Rasayana Avaleha 30gm per day for 30 day will be given and efficacy compared with palliative conservative medicine for cancer treatment or in follow up in cancer treatment.
Conclusion
·
Guduchyadi Karma Basti with Rasayana
Avaleha are better management for cancer patients to improving their
Quality of life.
·
Guduchyadi Karma Basti with Rasayana
Avaleha shows better management for cancer patients to reducing chief
complaint like Nusea, vomiting, Dysphasia constipation, fatigue abdominal pain,
localized pain and loss of appetite.
·
Guduchyadi Karma Basti with Rasayana
Avaleha able to pacify Urinary tract infection by reducing pus cell,
epithelial cell and albumin from urine
·
Guduchyadi Karma Basti with Rasayana
Avaleha more cost effective rather than other conventional modern
treatment and able to reduce economic burden of cancer patients and their
family
·
Thus, it is concluded
that Null hypothesis H0 and Alternative hypothesis H1 is rejected. While
Alternative hypothesis H2 is accepted. |