Effect of Bhadradi Kashaya as Oral Administration and as Basti Administration in the Management of Sthula Pramehi(Diabesity) and Obesity
- Conditions
- Healthy individuals as per Performa for Health Assessment by self reporting of CSIR Ayurgenomics Unit- TRISUTRA CSIR-IGIB, New DelhiType 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,
- Registration Number
- CTRI/2023/02/050014
- Lead Sponsor
- All India Institute Of Ayurveda
- Brief Summary
**This is a comparative study to investigate the effect of BhadradiKashaya administered Orally and as Kala Basti on the gut microbiome andmetabolite pattern in Sthula Pramehi(Diabbesity) and Sthula(HealthyObese).**
Metabolomics is the comprehensive characterization of metabolites inbiological systems. The metabolomes comprisesof small intermediary molecules and products of metabolism, including thoseassociated with energy storageand utilization, precursors to proteins and carbohydrates, regulators of geneexpression, and signalling molecules.Metaboliccharacterization of type 2diabetes mellitus (T2DM) is crucial for the identificationof individuals at risk for developing diabetes andT2DM-related vascular complications as well as for monitoring disease progression.
In Ayurveda, *Basti*(medicineadministered through anal route) is one ofthe major procedures described under *Panchakarma*for internalcleansing. 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 perayuvedic text *Bhadradi asthapana Basti*ishelpful ingetting relief from *lakshana(*symptom*) of kamla*(Jaundice*), pandu*(Anaemia)*, meh*(Diabetes mellitus)*, medasvi*(Obese)*, agni mandya(*derange state ofmetabolism*) kaphrogashan.*The aim of *Bastikarma*is to clean the body at both macro (gut) and micro channellevel up to the intracellular organelle and thus leading to a balancedstate of *Doshas*and *Agni*which in turn willhave a positive effect on gut physiology, digestion, improvement instrength, metabolism and hence resulting in a healthy state of body and mindas described in classical texts. Considering these factors, it is plannedto find out the impact of *Basti Karma*on Gut microbiomeand their metabolites in a widely prevalent metabolic disease *SthulaPramehi*(Diabesity)as previous studies indicates that type 2 diabetes in humans is associatedwith compositional changes in gut microbiome.
Diet and lifestylemodification being an integralpart of *Basti karma*may lead to the modification ofenvironmental microflora in a positive aspect for shaping the healthy humanmicrobiome and hence metabolite composition thus leading to the state of wellness. Thiswhole information gives a lead that *Basti*therapyaims at modulating the gut functioning and thereby restoring thestate of homeostasis, improving digestion and metabolism in turn can be proved to be an effectivetreatment. Therefore, this study can investigate the role of *Basti*therapyas described in Ayurveda byshowing its impact in the modulation of metabolites, biomarkers associated with obesity and T2DM and hence it can emerge as a proven modality oftreatment in variety of diseased conditions. In the *samprapti*of *Sthoulya*and *Prameha*inlater phase there is aggravation of *Vata*for which *Basti*is the mostpreferred treatment in Ayurveda; Further a specific *Basti*called *BadradiAsthapana Basti*is indicatedfor the pathological conditions like *Sthoulya*(Obesity), *Prameha*(Diabetes)hence this Basti is selected inthe modified form of *Kalabasti*in the present study on *SthulaPramehi*(patients with Diabesity) andthe same drugs of *Bahdradi Aasthaapan Basti*will be givenorally in both *Sthula Pramehi*(patients with Diabesity) and inhealthy 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 Prameh*i (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 –
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 lakshanaof Sthoulya and Prameha (administration of Bhadradi kasahay as Basti)
Group 2: Patient having lakshanaof 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 Group1&3
Procedure
*Deepan-Pachan -Vaishvanar churna for 3 days*
*Sthanikaabhyanga - Tila taila for 9 days*
*Sthanika nadisweda - 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 (katutorai), 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 3days
Oraladministration of *Bhadradi Kashaya*for 30 days O.D emptystomach
Total Durationof study- 34 days
Total Duration of Procedures- 18 days
Follow Up- after 15 days of completionof treatment.
PARAMETER FOR ASSESSMENT OF STUDY OUTCOMe
- Reduction in Sign and Symptoms of *Sthula Prameh*i (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- Bloodsample(for molecular analysis simultaneously along with the blood sample to becollected for Plasma Glucoselevel test) and stool sample formicrobiome analysis will alsobe collected for future analysis if resources and time would allow.
RESPONSECALCULATION AND ASSESSMENT OF RESPONSE:
The primary outcome measure of this study is to determinethe response (R) of the patientsto the therapy and it isproposed 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 45
-
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).
- Patients unfit for Basti Karma.
- Chronicity: More than 5yrs.
- 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.
- Individuals with co-morbidity like HTN (sthula individual).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). 0th,19th,34th day • 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 Measures
Name Time Method To see changes in Gut microbiome diversity To evaluate the quality of life.
Trial Locations
- Locations (1)
All India Institute Of Ayurveda
🇮🇳South, DELHI, India
All India Institute Of Ayurveda🇮🇳South, DELHI, IndiaDharam Singh MeenaPrincipal investigator9643068836dhrmmeena1996@gmail.com