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CTRI Number  CTRI/2023/02/050014 [Registered on: 23/02/2023] Trial Registered Prospectively
Last Modified On: 11/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [panchakarma]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Bhadradi Kashaya as Oral Administration and as Basti Administration in the Management of Sthula Pramehi(Diabesity) and Obesity 
Scientific Title of Study   An Experimental controlled clinical study to find the efficacy of Bhadradi kashaya administered orally and as Kala basti in the management of Sthulapramehi (Diabesity) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dharam Singh Meena 
Designation  PG Scholar 
Affiliation  All India Institute Of Ayurveda 
Address  OPD No.6, Department of Panchakarma, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
Room No.725, Academic Wing, Department Of Panchakarma, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076
South
DELHI
110076
India 
Phone  9643068836  
Fax    
Email  dhrmmeena1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh Kumar Bhatted 
Designation  Associate professor 
Affiliation  All india institute of ayurveda 
Address  Room No.703, Academic Wing, Department Of Panchakarma, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
Room No.703, Academic Wing, Department Of Panchakarma, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
South
DELHI
110076
India 
Phone  9414048459  
Fax    
Email  santoshbhatted@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dharam singh  
Designation  PG scholar 
Affiliation  AIIA 
Address  Room No.725, Academic Wing, Department Of Panchakarma, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
Room No.725, Academic Wing, Department Of Panchakarma, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
South
DELHI
110076
India 
Phone  9414048459  
Fax    
Email  dhrmmeena1996@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi- 110076 
AYUSH CoE Grant to CSIR-IGIB, Mathura Road, New Delhi 
 
Primary Sponsor  
Name  All India Institute Of Ayurveda 
Address  Gautampuri, Sarita Vihar, New Delhi-110076 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
CoE at CSIR IGIB  CSIR-IGIB, Sukhdev Vihar, New Delhi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dharam Singh Meena  All India Institute Of Ayurveda  OPD No.6, Department of Panchakarma, Gautampuri, Sarita Vihar, New Delhi
South
DELHI 		 9643068836

dhrmmeena1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insttutional Ethics Committee - All India Institute Of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals as per Performa for Health Assessment by self reporting of CSIR Ayurgenomics Unit- TRISUTRA CSIR-IGIB, New Delhi  
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, (2) 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: charak sutra 2/15, Procedure details: Basti karma(medicated decoction administered thhrough anal route))
(1) Medicine Name: Bhadradi, Reference: sushrut chikitsa 38/60-63, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 9 Days
(2) Medicine Name: Bhadradi Aasthaan, Reference: sushruta chikitsa 38/60-63, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 60(ml), Frequency: od, Duration: 30 Days
2Intervention ArmDrugClassical(1) Medicine Name: bhadradi kashayam, Reference: sushrut chikitsa , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
3Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: sushruta, Procedure details: medicated decoction enema will be given for 16 days )
(1) Medicine Name: bhadradikashayam , Reference: sushruta chikitsa, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 16 Days
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. BMI - >25-35
2.FBS –>126-300mg/dl
PPBS - >200-380mg/dl
3.HbA1c- >6.5-12
(Patient having classical symptom of sthula and prameha as per ayurvedic
text).
4.Waist-hip ratio-
Male -> 1
Female >0.86
5. Waist circumference-
Male - > 102 cm
Female- > 80cm
6.HbA1c- <5.7( for sthula individual)
 
 
ExclusionCriteria 
Details  1. Patients unfit for Basti Karma.
2. Chronicity: More than 5yrs.
3. Severe systemic diseases like- Pulmonary tuberculosis. Gestational
diabetes and malignancy
4. Patients with T2 DM exceeding the following plasma glucose limits-
a) Fasting plasma glucose values of ≥ 300mg/dL
b) RBS,PPBS≥ 380mg/dL
5. Juvenile Diabetes
6. Insulin dependent Diabetes mellitus
7. Individuals with co-morbidity like HTN (sthula individual)
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of Bhadradi Kashaya when administered Orally and as Basti in the management of Sthula Pramehi (Diabesity)based on clinical parameters(sign and symptoms of Pameha), Biomarker and stool metabolites(SCFA’s).
• To evaluate change in body weight and BMI, WHR in the patients of Sthula Pramehi (Diabesity) as well as healthy Obese.
 		 0th,19th,34th day
 
 
Secondary Outcome  
Outcome  TimePoints 
To see changes in Gut microbiome diversity
To evaluate the quality of life.
 		 0th,19th,34th day 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   01/03/2023 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a comparative study to investigate the effect of Bhadradi Kashaya administered Orally and as Kala Basti on the gut microbiome and metabolite pattern in Sthula Pramehi(Diabbesity) and Sthula(Healthy Obese). 

 

Metabolomics is the comprehensive characterization of metabolites in biological systems. The metabolomes comprises of small intermediary molecules and products of metabolism, including those associated with energy storage and utilization, precursors to proteins and carbohydrates, regulators of gene expression, and signalling molecules.Metabolic characterization of type 2 diabetes mellitus (T2DM) is crucial for the identification of individuals at risk for developing diabetes and T2DM-related vascular complications as well as for monitoring disease progression.

In Ayurveda, Basti (medicine administered through anal route) is one of the major procedures described under Panchakarma for internal cleansing. The Bhadradi Aasthapanabasti therapy includes Poorvakarma- sthanikaabhyanga (External oil massage) followed by sthanika Nadiswedana (Sudation) which is followed by Pradhankarma Basti dana(administration of drug through anal route). As per ayuvedic text Bhadradi asthapana Basti is helpful ingetting relief from lakshana(symptom) of kamla(Jaundice) , pandu(Anaemia), meh(Diabetes mellitus), medasvi(Obese), agni mandya(derange state of metabolism) kaphrogashan. The aim of Basti karma is to clean the body at both macro (gut) and micro channel level up to the intracellular organelle and thus leading to a balanced state of Doshas and Agni which in turn will have a positive effect on gut physiology, digestion, improvement in strength, metabolism and hence resulting in a healthy state of body and mind as described in classical texts. Considering these factors, it is planned to find out the impact of Basti Karma on Gut microbiome and their metabolites in a widely prevalent metabolic disease SthulaPramehi (Diabesity) as previous studies indicates that type 2 diabetes in humans is associated with compositional changes in gut microbiome.

Diet and lifestyle modification being an integral part of Basti karma may lead to the modification of environmental microflora in a positive aspect for shaping the healthy human microbiome and hence metabolite composition thus leading to the state of wellness. This whole information gives a lead that Basti therapy aims at modulating the gut functioning and thereby restoring the state of homeostasis, improving digestion and metabolism in turn can be proved to be an effective treatment. Therefore, this study can investigate the role of Basti therapy as described in Ayurveda by showing its impact in the modulation of metabolites, biomarkers associated with obesity and T2DM and hence it can emerge as a proven modality of treatment in variety of diseased conditions. In the samprapti of Sthoulya and Prameha in later phase there is aggravation of Vata for which Basti is the most preferred treatment in Ayurveda; Further a specific Basti called Badradi Asthapana Basti is indicated for the pathological conditions like Sthoulya (Obesity), Prameha (Diabetes) hence this Basti is selected in the modified form of Kalabasti in the present study on Sthula Pramehi (patients with Diabesity) and the same drugs of Bahdradi Aasthaapan Basti will be given orally in both Sthula Pramehi (patients with Diabesity) and in healthy obese to compare its effect when administered as Basti and orally.

 

 

OBJECTIVES OF THE RESEARCH PROJECT

 

Primary:

  • To compare the efficacy of Bhadradi Kashaya when administered Orally and as Basti in the management of Sthula Pramehi (Diabesity)based on clinical parameters(sign and symptoms of Pameha), Biomarker and stool metabolites(SCFA’s).
  • To evaluate change in body weight and BMI, WHR in the patients of Sthula Pramehi (Diabesity) as well as healthy Obese.

Secondary:

  • To see changes in Gut microbiome diversity
  • To evaluate the quality of life.

METHODOLOGY-

TYPE OF STUDY DESIGN - A randomized controlled clinical trial

SAMPLE SIZE CALCULATION â€“

This type of study is being done first time and further experiment procedure and test are costly. Therefore seeing the feasibility we have decided to take 15 individual in each group.

For recruitment in gr 1 and 2 Block Randomization will be used.

Group 1 : Patient having lakshana of Sthoulya and Prameha (administration of Bhadradi kasahay as Basti)

Group 2 : Patient having lakshana of Sthoulya and Prameha (Oral administration of Bhadradi kashaya)

No randomization will be required

Group 3 : Sthula without comorbdity like HTN otherwise healthy(administration of Bhadradi kasahay as Basti)

Total Sample Size = 45

 

 DRUG DELIVERY REGIMEN (DRUG, DOSE DURATION, FOLLOW-UP, WITHDRAWAL)

In Group 1&3

Procedure

Deepan-Pachan - Vaishvanar churna for 3 days

Sthanika abhyanga - Tila taila for 9 days

Sthanika nadi sweda - Dasmoola kwath for 9 days

Anuvasana Basti - Sarshapa taila for 6 days

Niruha Basti - Bhadradi kashaya for 9 days

Basti dravyas-

Kwath dravya- Bhadra(Katphala), Nimba, Kulatha, Arka, Koshataki (katu torai), Amruta(Guduchi), Amre(Devdaru), Sariva, Bruhati, Patha, Moorva, Aaragvadh, Vatsak(Kutaj)

Kalka dravya- Vacha, Madanphala, Sarshapa, Saindhev, Amar(Devdaru), Kushth, Ela,

Pippali, Bilva, Naagar(Shunthi)

Sneha dravya-  Sarshapa taila, Tila taila

Prakshep dravya- Yava kshar, Gomutra, Amla(Kaanji )

Saindhava

Madhu

     In Group 2

Procedures

 

Deepana- Pachan - Vaishvanar churna for 3 days

Oral administration of Bhadradi Kashaya for 30 days O.D empty stomach 

Total Duration of study- 34 days

Total Duration of Procedures- 18 days

Follow Up- after 15 days of completion of treatment.

 PARAMETER FOR ASSESSMENT OF STUDY OUTCOMe

  • Reduction in Sign and Symptoms of Sthula Pramehi (Diabesity) patients (By questionnaire Scoring Pattern of CSIR-IGIB).       
  • Targeted Metabolite analysis of stool through LC-MS,
  • Plasma Glucose level through intravenous blood sample of the patients.
  • QOL Questionnaire
  • Microbiota through 16s rRNA technology*.

Collection of specimens

  • Faecal Sample
  • Blood Sample*

 *Note- Blood sample(for molecular analysis simultaneously along with the blood sample to be collected for Plasma Glucose level test) and stool sample for microbiome analysis will also be collected for future analysis if resources and time would allow.

RESPONSE CALCULATION AND ASSESSMENT OF RESPONSE:

The primary outcome measure of this study is to determine the response (R) of the patients to the therapy and it is proposed to be measured in terms of the 

  • Reduction in sign and symptoms of Sthula Pramehi and plasma glucose levels.
  • Reduction in WHR, BMI.
  • Absence/reduction in the microbiome and metabolites associated with Diabesity and which are not  beneficial for metabolism.
  • Presence/increase in microbiome and metabolites helping in the prevention of Diabesity and which  are beneficial for metabolism.

 
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