FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/07/055312 [Registered on: 18/07/2023] Trial Registered Prospectively
Last Modified On: 05/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Panchakarma ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical trial to state the importance of Preventive panchakarma (basti vidhi) in prediabetics  
Scientific Title of Study   Study the effect of Panchtikta niruh basti in the management of sthool pramehi with special reference to diabetes mellitus (type-2) - Randomised controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tirth Mihirbhai Shah 
Designation  MD scholar 
Affiliation  Dr.G.D.Pol Foundation YMT Ayurved Medical college 
Address  Panchakarma dept.Dr.G.D.Pol foundation,YMT Ayurvedic college and hospital,institutional area kharghar

Raigarh
MAHARASHTRA
410210
India 
Phone  8169197188  
Fax    
Email  teerthshah1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kalpana Gholap Dhomse 
Designation  Hod and Associate professor, 
Affiliation  Dr.G.D.Pol Foundation YMT Ayurved Medical college 
Address  Panchakarma dept.Dr.G.D.Pol foundation,YMT Ayurvedic college and hospital,institutional area kharghar

Raigarh
MAHARASHTRA
410210
India 
Phone  9833971482  
Fax    
Email  kalpu.gholap@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kalpana Gholap Dhomse 
Designation  Hod and Associate professor, 
Affiliation  Dr.G.D.Pol Foundation YMT Ayurved Medical college 
Address  Panchakarma dept.Dr.G.D.Pol foundation,YMT Ayurvedic college and hospital,institutional area kharghar

Raigarh
MAHARASHTRA
410210
India 
Phone  9833971482  
Fax    
Email  kalpu.gholap@gmail.com  
 
Source of Monetary or Material Support  
YMT Ayurvedic College and hospital , Kharghar 
 
Primary Sponsor  
Name  Dr. Tirth Mihir Shah 
Address  Panchakarma dept.Dr.G.D.Pol foundation,YMT Ayurvedic college and hospital,institutional area kharghar 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tirth Mihir Shah  YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL , KHARGHAR   Ground Floor - OPD patients , GD pols YMT ayurvedic medical College and hospital sector 4 institutional area Kharghar ,navi mumbai - 410210
Raigarh
MAHARASHTRA 		 8169197188

teerthshah1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E138||Other specified diabetes mellituswith unspecified complications. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: चरकसंहितासिद्धिस्थानम् - ८.प्रासृतयोगीयासिद्धिः, Procedure details: Procedure details – Basti will be given for 8 days. 1) Sthanik mridu abhyang with Tilataila was done on udar- katinitamb-jangha-jaanu-paadpradesh of the patient. 2) Mridu nadi swedan 3)Matra basti with Til taila on day 1, 5 and 8. Niruh Basti - panchtikta niruh basti on days 2.3.4 and 6.7 (Four prasuta of the decoction of patola,nimba,bhunimba,rasna and saptacchada and one prasuta of cowghee should be added with the paste of sarshapa.This recipe is called Panchtiniruha basti.) Days of)
2Comparator ArmLifestyle--Dinacarya: vyayam udvartan, Ritucarya: non significant, Acara Rasayana:not applicable, Other:none, Pathya/Apathya:yes, Pathya:1)cereals - Millets (jowar , bajra, nachani , oats ) whole wheat , Rawa , Brown rice 2)pulses - all whole pulses and dals soyabean 3)Nuts and oilseeds - almonds , flaxseedas, chiaseeds 4)Milk products - chaas , cow milk , turmeric milk 5)Fruits -all other fruits 06)Oils - Sunflower oil , Rice bran, Olive oil, Soyabean oil 7)Non veg food - Eggs and chicken 8)others - small frequents meals , herbal tea ,homemade food 9)daily 15 mins of fast walking 10)luke warm water intake only, Apathya:1)cereals - white rice , maida, corn flour , sabudana 2)Nuts and Oilseeds - Cashews , Dried fruits , 3) milk and its products - paneer , curd 4)vegetables - Potatoes , Sweet Potato , yam , 5)Fruits - Fruit juices , Banana, Chickoo. Sitaphal mango, Musk melon, Papaya 6)Sugars and table sugars - jaggery , pastries , cakes, jam ,jellies ,icecreams , sweets 7)oils - dalda , palm oil , butter , mayyonnaise 8)Non veg food - red meat , organ meat and dried fish 9) others - papad pickles Deep
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  RECENTLY DIAGNOSED CASE OF TYPE -2 DM WITH
1.Blood Sugar Levels Fasting 100 mg/dl – 126 mg/dl
AND/OR
Blood Sugar Levels PostPrandial 140 mg/dl -199 mg/dl.
2.Glycosylated hemoglobin i.e. HbA1C - 5.7 – 6.4
3.BMI > 25 ( overweight) [19]]
4.Gender: Male & Female both
5.Age - 30 to 60 years 
 
ExclusionCriteria 
Details  TYPE-1 Diabetes Mellitus (IDDM) or patients who are currently on Insulin or any Oral Hypoglycemic Agents.
k/c/o ketoacidosis, diabetic coma, diabetic nephropathy ,
Uncontrolled Hypertension ,gangrene.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To asses hypoglycemic action of intervention group in Prediabetics by taking into consideration of these standard markers i.e.
1.BSL-Fasting & Postprandial
2. HBA1C

2)Compare the effect of panchtikta Niruh basti along with lifestyle modifications and specific diet in prediabetics. 		 1) BSL - FF AND PP ON
Baseline , 1 month and 3 months.
2)HBA1C on baseline and after 3 MONTHS . 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of Panchtikta Niruh Basti in improving BMI & Waist circumference .  DAY 0 AND DAY 90 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/08/2023 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Study summary -
This clinical trial is a controlled trial for MD dessertation under MUHS University .
total duration of trial - 3 years

Title name - Study the effect of Panchtikta niruh basti in the management of sthool pramehi with
special reference to diabetes mellitus (type-2) - Randomised controlled trial.

Intervention group - Panchtikta Niruh basti (panchkarma chikitsa)
control group - lifestyle modification and Diet ( as per clinically proven proforma and charts)

Groups
Group A - Intervention ( panchtikta Niruh basti kram - 8 days * 2 sittings ) + lifestyle modifications and Diet chart .
Group B -  Only  lifestyle modifications and Diet chart .

Duration -  Three months for each patient.

Name of student - Dr. Tirth Mihirbhai Shah

Name of Guide - Dr. Kalpana Gholap- Dhomse.




 
Close