| CTRI Number |
CTRI/2023/08/056897 [Registered on: 24/08/2023] Trial Registered Prospectively |
| Last Modified On: |
16/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To understand the efficacy of Mallotus nudiflorus (L.) (traditionally used substitute of Gambhari) and Gambhari (Gmelina arborea roxb.) in the patients of Sotha( General oedema) |
|
Scientific Title of Study
|
Evaluation of Mallotus nudiflorus (L.) Kulju & Welzen as an alternative to one of the Dashamoola plant Gambhari (Gmelina arborea Roxb) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijayalekshmi R |
| Designation |
Ph.D Scholar |
| Affiliation |
institute of teaching and research in Ayurveda, Jamnagar |
| Address |
3rd floor, Department of Dravyaguna, institute of teaching and research in Ayurveda, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
09567996480 |
| Fax |
|
| Email |
lekshmivijaya992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Bhupesh R Patel |
| Designation |
Associate Professor |
| Affiliation |
Institute of teaching and research in Ayurveda , Jamnagar |
| Address |
329, Department of Dravyaguna, Institute of teaching and research in Ayurveda , Jamnagar- 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
7487876343 |
| Fax |
|
| Email |
brpayu@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vijayalekshmi R |
| Designation |
Ph.D Scholar |
| Affiliation |
institute of teaching and research in Ayurveda, Jamnagar |
| Address |
3rd floor, Department of Dravyaguna, institute of teaching and research in Ayurveda, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
09567996480 |
| Fax |
|
| Email |
lekshmivijaya992@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda |
|
|
Primary Sponsor
|
| Name |
ITRA Hospital |
| Address |
Institute of Teaching and Research in Ayurveda, Opposite Reliance Mart,Jamnagar-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 |
| Vijaya Lekshmi R |
ITRA Hospital |
OPD NO.10,Department Of Dravyaguna, Institute of Teaching and Research in Ayurveda, Opposite Reliance mart,Jamnagar-361008
Jamnagar
GUJARAT |
9567996480
lekshmivijaya992@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:R601||Generalized edema. Ayurveda Condition: SOTHAH, (2) ICD-10 Condition:R601||Generalized edema. Ayurveda Condition: SVAYATHUH/SOTHAH/SOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Mallotus nudiflorus (L.) Kulju & Welzen , Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gambhari (Gmelina arborea Roxb), Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, 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 except Paittika Shotha and inflammatory swellings due to Abhighata or other causes
2.Patients of will be selected irrespective of sex,religion etc
3.Patients aged between 25-75 years |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from any systemic uncontrolled disease-like Diabetes(>180mg/dl), Hyper tension
(>160/100mm of Hg), Cardiac anomaly, Chronic renal failure, Liver cirrhosis, filariasis etc.
2.Pregnant or lactating mother
3.Patients exhibiting lakshanas of Paittika Shotha and inflammatory swellings due to Abhighata or
other causes.
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 on the basis of changes in scoring patterns and measurements of affected parts |
Changes in the Signs and Symptoms with measurements of affected parts will be assessed on zero and 14th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in routine Biochemistry, Blood & Urine investigations on 0th and 14th day |
zero & 14th day |
| changes in routine Biochemistry, Blood & Urine Investigation before & after treatment |
zero & 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)
|
01/01/2024 |
| 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 Mallotus nudiflorus (L.) in comparison to Gambhari (Gmelina arborea Roxb) in the management of Sotha. total 30 patients will be enrolled in the study. Selected patients will be divided into two groups on the basis of computer-generated randomization. in this study group A will be given Kwath of stem bark of Mallotus nudiflorus (50 ml twice a day after food ) for two weeks. and in Group B kwatha of stem bark of Gambhari (Gmelina arborea Roxb) (50 ml twice a day after food ) for two weeks. |