| CTRI Number |
CTRI/2024/01/060990 [Registered on: 01/01/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trail to study the effects of drug tamreshwar vati in patients with multiple lipomas. |
|
Scientific Title of Study
|
Clinical study on the efficacy of Tamreshwarvati in Medoj Granthi w.s.r to lipoma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr snehal patel |
| Designation |
PG scholar |
| Affiliation |
Dr BRKR Govt. ayurvedic medical college |
| Address |
Room No 6, shalyatantra O.P,Dr.BRKR. Government ayurvedic medical college,S.R Nagar,Hyderabad
Room NO 3, PG block DR BRKR Govt. ayurvedic medical college, Girls hostel,Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
09924525331 |
| Fax |
|
| Email |
patelmsnehal1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Sridhar |
| Designation |
Head of the department and professor |
| Affiliation |
Dr BRKR Government ayurvedic college, Hyderabad, Hyderabad |
| Address |
Room no 6, shalyatantara OP,Dr.BRKR.Govt ayurvedic medical collage,S.R Nagar Hyderabad, Telangana
Room no 7,third floor, Department of shalyatantra. DR BRKR Ayurvedic medical college, Hyderabad,Erragadda.
Hyderabad
TELANGANA
500018
India |
| Phone |
8309158194 |
| Fax |
|
| Email |
pgstdepartment@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Sridhar |
| Designation |
Head of the department and professor |
| Affiliation |
Dr BRKR Government ayurvedic college, Hyderabad, Hyderabad |
| Address |
Room no 6 shalyatantara OP,Dr.BRKR.Govt ayurvedic medical college and Hospital,S.R Nagar,Hyderabad,Telangana
Room NO 7,3rd floor,DR BRKR Govt ayurvedic medical college,S.R Nagar,Hyderabad, Telangana
Hyderabad
TELANGANA
500018
India |
| Phone |
8309158194 |
| Fax |
|
| Email |
pgstdepartment@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR BRKR Govt ayurvedic medical collage Erragadda, Hyderabad, Telangana 500018 |
|
|
Primary Sponsor
|
| Name |
Dr snehal patel |
| Address |
Dr BRKR government ayurvedic medical college Erragadda, Hyderabad, Telangana 500018 |
| Type of Sponsor |
Other [Self] |
|
|
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 snehal patel |
Dr BRKR Govt ayurvedic Hospital |
Room no 6, Department of shalya tantra
Hyderabad
TELANGANA |
09924525331
patelmsnehal1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of Dr BRKR government ayurvedic college Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: MEDOJAGRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tamreshwar vati, Reference: Rasendra sara samgraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -ushana jala), Additional Information: -avoid intake of ushna bhojana |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.History of occurrence of lipomas less than 15 years
2.Non infective lipomas.
3.multiple lipomas.
|
|
| ExclusionCriteria |
| Details |
1. History of occurrence of lipomas more than 15 years
2. Patients having age below 20 years and above 60 years
3. Solitary, Infective and having family history of lipomas
4. Lipomas associated with other types of growths like fibroid, neurofibroma, lymph adenomas, malignancy etc.
5. Diabetes mellitus, Heart diseases Malnutrition, Anemia, Hypertensive
6. Patient having other systemic pathology(TB, HIV/AIDS, HbsAG, VDRL REACTIVE)
7. Pregnancy and lactating Mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.reduces the size of multiple lipomas. |
Assessment done on baseline visit(day0) and after 2weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.the external appearance of growth reduces and make patent feel confident about his skin |
Assessment done on base line and after 4weeks of treatment |
|
|
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 |
|
Date of First Enrollment (India)
|
08/01/2024 |
| 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="6"
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
|
In the contemporary science the management of lipoma is surgical excision, liposuction and Lipolysis with steroids. But the surgery too has its own limitations as in the case of multiple Lipomatosis and the outcome of scar formation causes. psychological stress and apart from financial burden. Hence, there is a certain limitations in modern science but Ayurveda have very unique and great concept through which we can treat the conditions like lipoma. Treatment as per Ayurveda needs to be observed and evaluated, so that an economical and easy approachable treatment can be found for lipoma. |