| CTRI Number |
CTRI/2024/07/070013 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know and compare the shothhara karma - anti inflamatory activity of leaves and root of Agnimanth (Premna integrifolia Linn.) |
|
Scientific Title of Study
|
Evaluation of Shothahara Karma of leaves of Agnimantha (Premna
integrifolia Linn.) as an alternative to its Root |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nakum Banasree Damjibhai |
| Designation |
MD scholar |
| Affiliation |
Institute for post graduate teaching and research in Ayurveda Jamnagar |
| Address |
Department of Dravyaguna 3rd floor ITRA Jamnagar GUJARAT
361008 India Department of Dravyaguna 3rd floor ITRA Jamnagar
GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9974059893 |
| Fax |
|
| Email |
bansareenakum2212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Bhupesh R Patel |
| Designation |
Professor and HOD |
| Affiliation |
Institute for post graduate teaching and research in Ayurveda Jamnagar |
| Address |
Department of Dravyaguna 3rd floor Room no 329 ITRA Jamnagar
GUJRAT 361008 India Department of Dravyaguna 3rd floor Room
no 329 ITRA Jamnagar GUJRAT 361008 India
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
7487876343 |
| Fax |
|
| Email |
brpayu@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vd Bhupesh R Patel |
| Designation |
Professor and HOD |
| Affiliation |
Institute for post graduate teaching and research in Ayurveda Jamnagar |
| Address |
Department of Dravyaguna 3rd floor Room no 329 ITRA Jamnagar
GUJRAT 361008 India Department of Dravyaguna 3rd floor Room
no 329 ITRA Jamnagar GUJRAT 361008 India
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
7487876343 |
| Fax |
|
| Email |
brpayu@itra.edu.in |
|
|
Source of Monetary or Material Support
|
| Institute of teaching and research in Ayurveda jamnagar Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of teaching and research in Ayurveda jamnagar |
| Address |
Institute of teaching and research in Ayurveda,Opposite reliance mart, jamnagar Gujarat 361008 |
| 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 |
| Nakum Banasree |
PG Hospital institute of teaching and research in Ayurveda jamnagar Gujarat |
OPD no A-1 PG hospital
Dravyaguna,Institute of
teaching and research
in Ayurveda jamnagar
Gujarat
Jamnagar
GUJARAT |
9974059893
bansareenakum2212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,Institute of teaching and research in ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R609||Edema, unspecified. Ayurveda Condition: SVAYATHUH/SOTHAH/SOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Agnimanth moola churna, Reference: Bhavprakash guduchyadi varga, 24, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -ushnodak), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Agnimanth patra churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -ushnodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with the classical signs and symptoms of Shotha with less than 3 months
Of chronicity.
2. Shotha due to hypothyroidism, generalized anasarca and hypoproteinaemia will be included
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from any systemic uncontrolled disease like
Diabetes, hypertension, cardiac anomaly,
Chronic renal failure, Liver cirrhosis, filariasis, etc.
2.Pregnant or lactating mother.
3.Patients exhibiting lakshanas of aagantuj Shotha.
4.Patients suffering from any auto immune diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Improvement in condition will be assessed based on changes in scoring patterns developed
for grading of these clinical factors on 0th and 14th day.
•Change in oedema pitting measurement of affected parts on0th and 14th day.
|
Out comes will be assessed on 0th and 14th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •Change in routine biochemistry, Blood and Urine investigations |
On 0th and 14th day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="0"
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
|
This trial is randomized clinical trial to evaluate the efficacy of Agnimanth Patra Churna ( premna integrifolia Linn) in compare to Agnimanth moola Churna in the management of Shotha. selected patients will be divided in to two group on basis of computer generated randomization. in this study both the group will receive drug in dosage of 6g churna after food twice a day for 14 day.
|