| CTRI Number |
CTRI/2025/05/086823 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of panchakarma treatment like virechana and basti in type 2 diabetes |
|
Scientific Title of Study
|
To Evaluate the add on effect of Virechana followed by Basti on Mitochondrial Dysfunction assessed through Humanin in Patient of Type 2 Diabetes (Prameha) – An open labelled Randomized Standard Controlled Clinical Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devika Bhuva |
| Designation |
PhD Scholar |
| Affiliation |
ITRA Jamnagar |
| Address |
4th floor, panchakarma department, institute building, ITRA , Jamnagar, pin. 361008
To.Dhudasiya
Ta. Gondal
Dis.Rajkot
Pin. 364470
Jamnagar
GUJARAT
361008
India |
| Phone |
08758820690 |
| Fax |
- |
| Email |
devikabhuva@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Dr. Anup Thakar |
| Designation |
Professor |
| Affiliation |
ITRA Jamnagar |
| Address |
4th floor, panchakarma department, institute building, ITRA , Jamnagar, pin. 361008
4th floor, panchakarma department, institute building, ITRA , Jamnagar, pin. 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
- |
| Email |
anup_Thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Devika Bhuva |
| Designation |
PhD Scholar |
| Affiliation |
ITRA Jamnagar |
| Address |
4th floor, panchakarma department, institute building, ITRA , Jamnagar, pin. 361008
To.Dhudasiya
Ta. Gondal
Dis.Rajkot
Pin. 364470
GUJARAT
361008
India |
| Phone |
08758820690 |
| Fax |
- |
| Email |
devikabhuva@gamil.com |
|
|
Source of Monetary or Material Support
|
| ITRA HOSPITAL,Gurudwara Rd.,opp.B division police station, near reliance smart, jamnagar, gujrat 361008 india
|
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Primary Sponsor
|
| Name |
ITRA Institute |
| Address |
Gurudwara Rd, opp. B Division Police Station, near Reliance Smart, Valkeshwari, Park Colony, Jamnagar, Gujarat 361008 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrDevika Bhuva |
ITRA |
4th floor, panchakarma department, institute building, Institute of Teaching and Research in Ayurveda , Jamnagar, pin. 361008
To.Dhudasiya
Ta. Gondal
Dis.Rajkot
Pin. 364470
Jamnagar
GUJARAT |
08758820690
devikabhuva@gamil.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITRA |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म & BASTI | (Procedure Reference: Charaka samhita, Vidyotini hindi commentary edited by pt. Kashinath shastri, published by choukhambha Bharati academy, Varanasi – ch.k.7/29, Procedure details: For Deepana & Pachana, take 3 grams of Trikatu Powder twice a day with warm water for 3 to 5 days. During Snehapana, consume Tila Taila (Sesamum oil) for a duration of 3 to 7 days. Follow up with Abhyanga & Bashpa Swedana using Bala Oil (Sida cordifolia Linn.) for 3 days. On the designated day for Virechana Karma, use Trivrittadi Yoga. After that, adhere to the Samsarjana Karma diet plan based on Shuddhi for 3 to 7 days.
For Madhutailika Basti, the treatment lasts for 8 days and consists of the Take 100 grams of Madhu (Mel depuratum), followed by 12 grams of Saindhava (Rock salt). Use 100 ml of Tila Taila (Sesamum indicum Linn.) as seed oil. Include 24 grams of Shatpushpa Kalka (Peucedanum graveolens Linn.), which comes from the fruit. Lastly, consume 200 ml of Eranda Moola Kwatha (Ricinus Communis Linn.), extracted from the root.
)
(1) Medicine Name: Trivrittadi Yoga , Reference: Charaka samhita, Vidyotini hindi commentary edited by pt. Kashinath shastri, published by choukhambha Bharati academy, Varanasi – ch.k.7/29, Route: Oral, Dosage Form: Churna/ Powder, Dose: 25(g), Frequency: od, Duration: 1 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Metformin/ Combination of Metformin | Time of administration 30 min prior to breakfast and dinner.
Route of administration orally
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient having three or more signs and symptoms of the disease.
Freshly diagnosed patients and patient with ongoing medication (metformin/combination of metformin) of Type 2 Diabetes with blood sugar level- FBS - 126 to 220 mg/dl or
PPBS - 200 to 300 mg/dl or Age group of 30-65 years.
Patient fit for Virechana and Basti Karma.
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| ExclusionCriteria |
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Increase Sr. Humanin (HN) level |
4th week of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction the levels FBS & PPBS
Improvement in the quality of Life in Diabetic Patients.
|
4th week of treatment |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/06/2025 |
| 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="3"
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
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Brief Summary
|
this research explores whether an ayurvedic treatment like virechana and basti can help to improve the health in diabetes patients. in type two diabetes the tiny power plants in our cells called mitochondria don’t work properly. this can lower energy levels make the body less responsive to insulin and allow harmful waste to build up inside and around cells. ayurvedic treatment like virechana might belp by flushing out these wastes improving how these cell power plants work. another treatment basti improves gut health which can boost mitochondrias function by producing helpful enzymes and hormones. the study will test panchakarma procedure like virechana and busti which can enhance the activity of mitochondria in diabetic patient. 100 patients aged between 30 to 60 years with fbs 126mg/dl or ppbs 200mg/dlpatient having symptoms of type 2 diabetes will participate they will be divided into two groups in group A 50 patients will receive virechana and basti and in group B 50 patient will receive metformin. study period is four weeks symptoms of diabetes biomarkers and who DQOL will be assessed before and after treatment if any positive findings are obtained in mitochondrial dysfunction then it will be great boost to explore this part of the treatment in future and treatment plan for many diseases can be made by considering this abnormality of the cell |