| CTRI Number |
CTRI/2024/03/064696 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of metabolic syndrome with the help of rukshana therapy and udvartana ,lekhana vasti |
|
Scientific Title of Study
|
TO EVALUATE THE THERAPEUTIC EFFICACY OF RUKSHANA,UDVARTANA,LEKHANA BASTI IN MEDOROGA W.S.R TO METABOLIC SYNDROME |
| Trial Acronym |
Mets |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Patlolla Manisha |
| Designation |
PG Scholar[MD] |
| Affiliation |
Dr BRKR Government Ayurvedic Medical College and Hospital |
| Address |
Room no:5,Panchakarma department,Dr BRKR Government Ayurvedic medical college and Hospital ,Opp ESI Hospital,AG Colony road,Erragadda,Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9959137718 |
| Fax |
|
| Email |
patlolla.manisha7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Kumar Madikonda |
| Designation |
Associate Professor |
| Affiliation |
Dr BRKR Government Ayurvedic medical college and Hospital |
| Address |
Room no:5,Panchakarma department,Dr BRKR Government Ayurvedic medical college and Hospital ,Opp ESI Hospital,AG Colony road,Erragadda,Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9849271601 |
| Fax |
|
| Email |
pkmadikonda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Kumar Madikonda |
| Designation |
Associate Professor |
| Affiliation |
Dr BRKR Government Ayurvedic medical college and Hospital |
| Address |
Room no:5,Panchakarma department,Dr BRKR Government Ayurvedic medical college and Hospital ,Opp ESI Hospital,AG Colony road,Erragadda,Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9849271601 |
| Fax |
|
| Email |
pkmadikonda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BRKR Government Ayurvedic medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr BRKR Govt Ayurvedic medical college and hospital |
| Address |
Opp ESI Hospital,AG Colony road,Erragadda ,Hyderabad |
| 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 Patlolla manisha |
DR. BRKR GOVT. AYURVEDIC COLLEGE AND HOSPITAL, ERRAGADDA, HYDERABAD |
Op. no 5, Dr. BRKR Govt. ayurvedic college and hospital, erragadda, hyderabad, 500018, telangana
Hyderabad
TELANGANA |
9959137718
patlolla.manisha7@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 affliliated to Kaloji narayan rao university of health sciences ,warangal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | udvartanam, उदà¥à¤µà¤°à¥à¤¤à¤¨à¤®à¥ | (Procedure Reference: , Procedure details: )
| | 2 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: )
| | 3 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:
, Pathya/Apathya:yes, Pathya:On empty stomach:Madhoodaka[honey water]-20 ml with 200 ml water
After lunch:Takrapana(buttermilk)-200 ml
After dinner:Haritaki churna-4 grams with lukewarm water
Includes barley roti,leafy vegetables ,fiber rich diet., Apathya:atisnigdha,newly harvested rice,nava madya,anupa mamsa,diwa swapna,aversion to physical exercise etc |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical signs and symptoms of medoroga metabolic syndrome
Patients who are eligible for rukshana vasti karma udvartana
Patients who are willing to sign the consent form |
|
| ExclusionCriteria |
| Details |
Patients aged below 20 and above 60 years
Pregnant and lactating women
Patients who are not eligible for rukshana,udvartana,lekhana vasti
Patients who are having major illness like IDDM,DM which is poorly controlled
Patients who have a history of untreated thyroid disorders,uncontrolled hypertension
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of body weight,BMI and Reduction in two or more than two factors in metabolic syndrom |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To give symptomatic relief and to improve quality of life |
8 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2024 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is a randomised clinical trial on the therapeutic efficacy of rukshana,udavartana,lekhana basti in medoroga w.s.r to metabolic syndrome who will be clinically diagnosed and confirmed cases of metabolic syndrome enlisted in inclusion criteria will be in single group of total 30 patients. They will be given Honey[20ml] on empty stomach for 60 days they will be given buttermilk [200ml] after lunch for 60 days they will be given haritaki churna [3-4 gms ]with lukewarm water for 60 days from day 26-32 [1st sitting] of udvartana with kolakulathadi churna for 30-45 minutes gap for 7 days from day 40-46 [2nd sitting] of udvartana with kolakulathadi churna for 30- 45 minutes gap of 7 days from day 54-60 lekhana vasti for 7 days saindhava lavana 6 grams , makshika 100 ml , tila taila 100 ml ,kalka :musta,triphala,satapuspha -30 grams,triphala kwath -200 ml,gomutra-200ml,yava kshara 7-10 grams following rukshana diet such as green gram sprouts for breakfast ,two barley roti once/twice in a day , follow up to 60 days with review on 25th day,32nd day,46th day ,60th day |