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CTRI Number  CTRI/2025/03/082770 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 05/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study Comparing Two Ayurvedic Enema Therapies (Rasnadi Basti and Madhutailika Basti) for Managing Type 2 Diabetes 
Scientific Title of Study   A randomized comparative clinical study on the effect of rasnadi basti and madhutailika basti in the management of prameha with special reference to type 2 diabetes mellitus 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dhanashri Khandebharad 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurved  
Address  Panchakarma-OPD No.105 and IPD, Parul Ayurved Hospital, Parul University, Limda, Tal. Waghodia-391760, Dist-Vadodara GUJARAT India

Vadodara
GUJARAT
391760
India 
Phone  9503283865  
Fax    
Email  08dhanashri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nirmala Sonawane 
Designation  Professor  
Affiliation  Parul Institute of Ayurved  
Address  Room No.303 Department Of Panchakarma, Parul Institute of Ayurved, Parul University, Limda, Tal. Waghodia-391760, Dist-Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  8329614671  
Fax    
Email  ayurved05@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nirmala Sonawane 
Designation  Professor  
Affiliation  Parul Institute of Ayurved  
Address  Room No.303 Department Of Panchakarma, Parul Institute of Ayurved, Parul University, Limda, Tal. Waghodia-391760, Dist-Vadodara GUJARAT 391760 India

Vadodara
GUJARAT
391760
India 
Phone  8329614671  
Fax    
Email  ayurved05@gmail.com  
 
Source of Monetary or Material Support  
Parul Institute of Ayurved, PO Limda, Tal. Waghodiya 391760, Vadodara, Gujrat, India 
 
Primary Sponsor  
Name  Parul Ayurved Hospital  
Address  Parul Ayurved Hospital, Parul University, Limda, Tal. Waghodia-391760, Dist-Vadodara GUJARAT India 
Type of Sponsor  Research institution and hospital 
 
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 Dhanashri Khandebharad  Parul institute of ayurved  Panchakarma OPD No 105 and IPD, Parul Ayurved Hospital, Parul University, Limda, Tal Waghodia 391760, Dist Vadodara GUJARAT India
Vadodara
GUJARAT 
9503283865

08dhanashri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intitutional Ethics Committee for human research, Parul institute of Ayurved, Parul university.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Sushrut Chikitsa Sthan 38/114, Procedure details: Madhutailika Basti For 6 Days Containing Madhu 150 ml; Saidhav 12 gm; Sneha 150 ml Murchita Tila Taila; Kalka 30 gm Satpushpa Kalka; Kashay 200 ml Erandamoola Kashay along with Anuvasana Basti For 10 Days Containing Murchita Tila Taila 70 ml. Basti Schedule Day 1 Anuvasan basti, Day 2 Niruha & Anuvasana Basti, Day 3 Niruha & Anuvasana Basti, Day 4 Niruha & Anuvasana Basti, Day 5 Niruha & Anuvasana Basti, Day 6 Niruha and Anuvasana Basti, Day 7 Niruha and Anuvasana Basti, Day 8 Anuvasana Basti, Day 9 Anuvasana Basti, Day 10 Anuvasana Basti.)
(1) Medicine Name: Madhutailika Basri, Reference: Sushrut Chikitsa Sthan 38/114, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 542(ml), Frequency: od, Duration: 10 Days
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charaka Samhita Siddhi Sthan 3/61-64, Procedure details: Rasnadi Niruha Basti For 6 Days Containing Madhu 140 ml; Saindhav 12 gm; Sneha 100 ml Murchit Tila Taila; Kalka 30 gm Rasnadi Kalka; Kashay 200 ml Rasnadi Kashay; Aavap 100 ml Go Mutra along with Anuvasana Basti For 10 Days Containing Murchit tila taila 70 ml. Basti Schedule Day 1 Anuvasan basti, Day 2 Niruha & Anuvasana Basti, Day 3 Niruha & Anuvasana Basti, Day 4 Niruha & Anuvasana Basti, Day 5 Niruha and Anuvasana Basti, Day 6 Niruha and Anuvasana Basti, Day 7 Niruha and Anuvasana Basti, Day 8 Anuvasana Basti, Day 9 Anuvasana Basti, Day 10 Anuvasana Basti.)
(1) Medicine Name: Rasnadi Basti, Reference: Charaka Samhita Siddhi Sthan 3/61-64, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 582(ml), Frequency: od, Duration: 10 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  The patients for this study will be selected randomly irrespective of their sex, religion,
caste etc.
1. Age between 18 to 70 years.
2. Patients indicated for Basti .
3. Patients with symptoms of Prameha and type 2 diabetes mellitus.
4. Patients diagnosed with diabetes mellitus type 2.
5. Patients willing for clinical trial. 
 
ExclusionCriteria 
Details  The cases with complications like diabetic gangrene, carbuncles, diabetic coma, diabetic
retinopathy, diabetic neuropathy.
1. Insulin Dependant Diabetes Mellitus.
2. Ischemic Heart Disease.
3. Patients not willing for clinical trial 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
This study will compare the effects of Rasnadi Basti and Madhutailika Basti in managing Type 2 Diabetes by assessing improvements in blood glucose levels, insulin resistance, and metabolic functions.  13 days 
 
Secondary Outcome  
Outcome  TimePoints 
This study will explore the impact of these Basti therapies on diabetes symptoms, balance doshas, prevent complications  63 days 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   10/04/2025 
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="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  
Introduction :

Basti, a key Ayurvedic Panchakarma therapy, involves administering medicated oils or decoctions through the rectum to balance doshas, particularly Vata. Acharya Charaka considers it "Ardha Chikitsa."

Prameha, a chronic Tridosha disorder, mainly involves Kapha imbalance, impaired metabolism, and dysfunction of Dhatus and Strotas, leading to excessive urination and systemic symptoms. Poor diet, sedentary lifestyle, and genetics contribute to its development.

Diabetes Mellitus is a metabolic disorder marked by chronic hyperglycemia due to insulin deficiency or resistance. WHO defines it as a chronic disease caused by insufficient or ineffective insulin.

Rasnadi Basti may help in managing Prameha by targeting Meda Dhatu, improving metabolism, and reducing insulin resistance. Madhutailika Basti, prepared with honey and oil, is beneficial for chronic Vata disorders and may help regulate blood glucose levels.

Need of study :

Diabetes is a growing global health challenge, with cases rising from 108 million in 1980 to 537 million in 2021. It caused 6.7 million deaths in 2021, with a higher burden in low and middle-income countries. The global prevalence of type 2 diabetes is 6.1%, but in India, it is significantly higher at 11.4%. Projections estimate 643 million cases by 2030 and 784 million by 2045. India, heavily affected, had 77 million diabetics in 2019, with Gujarat alone recording 1,61,578 cases in 2015. These trends highlight the urgent need for public health interventions. Till now no such research has been conducted to evaluate the effects of Rasnadi Basti in the management of Prameha. Hence keeping this in view the present study is planned to evaluate the efficacy of Rasnadi Basti and Madhutailika Basti in the management of Prameha w.s.r. to Type 2 Diabetes.

Research question :

Is Rasnadi  Basti  effective in the  management of Prameha  with special reference to type 2 diabetes mellitus or not ?

Aims and objectives:

Aim : To study the effect of Rasnadi  Basti  and Madhutailika  Basti  in the management of Prameha  W.S.R.  to Type 2 Diabetes Mellitus.

Objectives:

1.       To study the clinical effects of Rasnadi  Basti  in the management of Prameha  with reference to Type 2 Diabetes Mellitus.

2.       To study the clinical effects of Madhutailika  Basti  in the management of Prameha  with reference to Type 2 Diabetes Mellitus.

3.       To compare the clinical effects of Rasnadi Basti and Madhutailika  Basti  in the management of Prameha  with reference to Type 2 Diabetes Mellitus.

Methodology :

Materials And Methods:

1.        Sources of data :

(a)     Literary source:

All the available classical, modern literature and contemporary texts including the journals and online websites regarding the Prameha, Basti  Karma and Diabetes Mellitus type 2 will be reviewed and documented for the study.

(b)     Pharmaceutical source :

Medicine will be prepared in the GMP certified Pharmacy of Parul Institute of Ayurved.

(c)     Clinical source:

Diagnosed cases of Prameha, will be selected from OPD and IPD of Parul Ayurved Hospital, Limda, Vadodara, and Khemdas Ayurved Hospital, Ishawarpura, Vadodara, and  Parul Sevashram Hospital, Vadodara and special campaigns  fulfilling the criteria of selection and who are willing to participate in the present study will be included for the clinical study.

Method of collection of data:

a)       Sample size: 44

b)      Study design: Comparative Clinical Trial with pre and post assessment.

c)       Study Duration: 18 months

d)      Duration of treatment: 13 days

Treatment Group :

1.       Group A – Rasnadi Basti

2.       Group B – Madhutailika Basti

Diagnostic criteria : According to the American Diabetes Association (ADA) 

1. Glycated hemoglobin test - 6.5 % 0r > 6.5 %

2. Fasting plasma glucose level - = 126 mg/dl or > 126 mg/dl (7.0 mmol/L)

3. Post prandial plasma glucose level - = 200 mg/dl > 200 mg/dl ( 11.1 mmol/L)

Assessment criteria :

Subjective criteria

·         According to WHO – Scoring of Ayurveda Symptoms- GAU

1.       Prabhuta Mutrata (Polyuria)

2.       Mutramadhurya (Glycosuria)

3.       Pipasa-Adhikya (Increased Thirst)

4.       Kshudha-Adhikya (Increased Appetite)

5.       Swedadhikya (Perspiration)

6.       Angagandha (Bad odour)

7.       Nidradhikya (Increased Sleep)

8.       Hasta-Pada-Tala Daha

9.       Kara-Pada Suptata

·         Improvement of quality of life: It will be assessed by Quality of Life Instrument for Indian Diabetes Patients-

1.       Role limitation due to physical health (Social life, work, traveling)

2.       Physical Endurance

3.       General Health

4.       Treatment Satisfaction

5.       Symptom Botherness

6.       Financial Worries

7.       Emotinal/Mental health

8.       Diet Advice Tolerance

Objective criteria

1.       Fasting blood sugar level (FBS)

2.       Post prandial blood sugar level (PP2BS)

3.       HbA1c

Intervention:

44 Patients of Prameha  who fulfills the inclusion criteria will be randomly selected and assigned into following 2 groups each comprising of 22 patients.

Group A – Rasnadi Basti – 22 patients. Each patient will be subjected to Rasnadi basti.

Group B – Madhutailika Basti - 22 patients. Each patient will be subjected to Madhutailika basti.

Duration – 10 days as per kala basti krama.

The effect of Basti chikitsa will be assessed by following criteria-

1. Basti adana kala
2.Basti pratyagamana kala
3.Dharana kala
4. Samyaka niruha basti lakshanas
5. Samyaka anuvasan basti lakshanas

 
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