| CTRI Number |
CTRI/2024/07/071712 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical Study on Steam bath after Powder massage and Pouring medicated water after Powder massage followed by Purgation thearapy in Diabetes Mellitus |
|
Scientific Title of Study
|
A Comparative Clinical Study On Bashpa Swedana after Udwartana and Parisheka after Udwartana followed by Virechana Karma in Sthula Madhumeha vis a vis Type 2 Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 12 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MANJUNATHARAO SV |
| Designation |
PG SCHOLAR |
| Affiliation |
skamch rc |
| Address |
skamch rc 10 pipeline road Vijayanagara 2nd stage rpc layout Bengaluru
Department of Panchakarma Opd number 01 skamch rc 10 pipeline road Vijayanagara 2nd stage rpc layout Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
7022689358 |
| Fax |
|
| Email |
svmanjunatharao15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KIRAN M GOUD |
| Designation |
PROFESSOR |
| Affiliation |
skamch rc |
| Address |
skamch rc 10 pipeline road vijayanagara 2nd stage rpc layout Bengaluru
Department of panchakarma opd number 01 skamch rc 10 pipeline road vijayanagara 2nd stage rpc layout Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
9845109556 |
| Fax |
|
| Email |
kiranmgoud@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR KIRAN M GOUD |
| Designation |
PROFESSOR |
| Affiliation |
skamch rc |
| Address |
skamch rc 10 pipeline road vijayanagara 2nd stage rpc layout Bengaluru
Department of panchakarma opd number 01 skamch rc 10 pipeline road vijayanagara 2nd stage rpc layout Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
9845109556 |
| Fax |
|
| Email |
kiranmgoud@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Center10 Pipeline road Vijayanagara 2nd stage rpc layout Bengaluru karnataka india 560104 |
|
|
Primary Sponsor
|
| Name |
Dr Manjunatharao SV |
| Address |
Department of panchakarma opd number 01 Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Center 10 pipeline road Vijayanagara 2nd stage rpc layout Bengaluru karnataka india 560104 |
| Type of Sponsor |
Other [Other ] |
|
|
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 Kiram M Goud |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Center Bengaluru |
Department of panchakarma opd number 01 skamch rc 10 pipeline road vijayanagara 2nd stage rpc layout Bengaluru
Bangalore Rural
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCH and RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: charaka samhita,chikitsa sthana chapter 6/50, Procedure details: Sarvanga udwartana with triphala choorna followed by parisheka with karanja patra kwatha for duration of 30 minutes for a cource of 7 days followed by virechana karma in sthula madhumeha. vis a vis type 2 diabetes mellitus )
| | 2 | Intervention Arm | Procedure | - | uShNasadanam, उषà¥à¤£à¤¸à¤¦à¤¨à¤®à¥ | (Procedure Reference: sushruta samhita, chikitsa sthana chapter 32/3, Procedure details: Sarvanga udwartana with triphala choorna followed by Bashpa swedana with karanja patra kwatha for duration of 30 minutes for a cource of 7 days followed by virechana karma in sthula madhumeha. vis a vis type 2 diabetes mellitus )
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects presenting with the Lakshanas of Sthula Madhumeha.
2 Subjects presenting with signs and symptoms of Type 2 Diabetes Mellitus.
3 Subjects of irrespective of gender in between age group of 20 to 60 years.
4 Subjects fit for Rookshana Karma.
5 Subjects fit for Virechana Karma.
|
|
| ExclusionCriteria |
| Details |
Subjects presenting with the history of Juvenile diabetes, Gestational diabetes, Type I diabetes mellitus, and any other systemic diseases which may interfere with the course of treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| How Bashpa swedana and Parisheka followed by virechana karma acts in sthula madhumeha vis a vis type 2 diabetes mellitus |
Before Treatment
After Treatment (1week)
After Virechana karma (2week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
12/08/2024 |
| 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 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
|
Hence, the present study has been undertaken to compare the efficacy of Bashpa Swedana with Karanjapatra kwatha after Udwartana, and after Abhyanga during vishrama kala, as Samanya poorvakarma for Virechana karma and Parisheka with Karanjapatra kwatha after Udwartana, and after Abhyanga in vishrama kala, as Vishista poorvakarma for Virechana Karma in the management of Sthula Madhumeha vis a vis Type 2 Diabetes Mellitus. |