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CTRI Number  CTRI/2026/01/102459 [Registered on: 29/01/2026] Trial Registered Prospectively
Last Modified On: 28/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [siravedhan]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to evaluate the effect of bloodletting therapy along with herbal medicine compared to herbal medicine alone in patients with fatty liver disease 
Scientific Title of Study   A Comparative Clinical Study of Siravedhana and Sarpunkhadi Churna Versus Sarpunkhadi Churna Alone in the Management of Non-Alcoholic Fatty Liver Disease NAFLD 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dhruv Kachhia  
Designation  PG SCHOLAR 
Affiliation  Shree Swaminarayan Ayurvedic College kalol 
Address  Department of shalya Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway AT and PO Saij Ta Kalol Dist Gandhinagar 382725 GUJARAT India

Gandhinagar
GUJARAT
382725
India 
Phone  8488909104  
Fax    
Email  kachhia2208@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr anita patel  
Designation  BAMS MS PHD SHALYA PROFESSOR 
Affiliation  Shree Swaminarayan Ayurvedic College kalol 
Address  Department of shalya Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway AT and PO Saij Ta Kalol Dist Gandhinagar 382725 GUJARAT India

Gandhinagar
GUJARAT
382725
India 
Phone  9176945090  
Fax    
Email  dranitasudha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr anita patel  
Designation  BAMS MS PHD SHALYA PROFESSOR 
Affiliation  Shree Swaminarayan Ayurvedic College kalol 
Address  Department of shalya Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway AT and PO Saij Ta Kalol Dist Gandhinagar 382725 GUJARAT India


GUJARAT
382725
India 
Phone  9176945090  
Fax    
Email  dranitasudha@gmail.com  
 
Source of Monetary or Material Support  
Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway AT and PO Saij Ta Kalol Dist Gandhinagar 382725 GUJARAT India 
 
Primary Sponsor  
Name  Shree Swaminarayan Ayurvedic College kalol 
Address  Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway AT and PO Saij Ta Kalol Dist Gandhinagar 382725 GUJARAT India 
Type of Sponsor  Private hospital/clinic 
 
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 Dhruv Kachhia  Premswarup Swami Ayurvedic Multispecialty Hospital  OPD 006 Department of shalya Premswarup Swami Ayurvedic Multispeciality Hospital Ahmedabad Mehsana Highway At and Po Saij Ta Kalol Dist Gandhinagar 382725 GUJARAT
Gandhinagar
GUJARAT 
8488909104

kachhia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Shree Swaminarayan AInstitutional Ethics Committee Shree Swaminarayan Ayurvedic College and Hospital Kalol  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: Shu. Chi. Udarrog adhyay, Procedure details: Site clean with betadine swab, Siravedha done with 18 number needle & blood letting done. needle remove & dressing done.)
2Comparator ArmDrugClassical(1) Medicine Name: sarpunkhadi churna, Reference: bhavprakash 6/ghritavarga shloka 759, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18 60 years
Diagnosed case of fatty liver
BMI greater than 24
Elevated lipid profile of grade 2 non-alcoholic fatty liver diesease
Total Cholesterol Less than 400 mg per dL
LDL Cholesterol Less than 200 mg per dL optimal
HDL Cholesterol less than 40 mg per dl
Triglycerides Less than 500 mg per dL.
Informed and written consent for participant
 
 
ExclusionCriteria 
Details  NAFLD Grade 3 or cirrhosis
Diabetes RBS greater than 200
Hb less than 10
Pregnancy or lactation
Bleeding disorders
Alcoholic liver disease
Coagulopathies
Acute abdominal pain
Contraindications of raktmokshan
 
 
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 
Reduction in fatty liver grading on USG after 45 days in the intervention group  baseline and 90th day 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in lipid profile and BMI
Relief in subjective complaints like abdominal heaviness bloating and fatigue
 
baseline and 90th day 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   08/02/2026 
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="0"
Months="11"
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
Brief Summary  

  Non-Alcoholic Fatty Liver Disease NAFLD is a progressively increasing metabolic liver disorder characterized by excessive fat accumulation in hepatocytes without significant alcohol consumption It encompasses a clinical spectrum ranging from reversible steatosis to non alcoholic steatohepatitis fibrosis cirrhosis and hepatocellular carcinoma Grades 1 and 2 representing early stages commonly manifest with mild steatosis metabolic imbalance abdominal discomfort bloating fatigue and altered liver echotexture on ultrasonography Lifestyle modifications including weight reduction exercise and controlled dietary habits are the primary line of modern management while pharmacotherapy is considered adjunctive for metabolic comorbidities

In Ayurveda NAFLD can be correlated with Yakruta vikar Medodusti and Agnimandya where impaired Jatharagni and Medodhatvagni lead to Ama formation Kapha Medo accumulation and obstruction of Raktavaha srotas Siravedhana a form of Raktamokshana described extensively in Brihattrayi particularly by Sushruta is indicated in conditions of Rakta Pitta aggravation and Yakruta pleeha vikaras It promotes expulsion of vitiated blood reduces inflammatory load and restores doshic equilibrium Sanskrit references specify Siravedhana at right upper extremity sites for Yakrut disorders Sharapunkhadi Churna comprising Sharapunkha Bhumiamalki and Katuki  is a hepatoprotective formulation possessing Deepana Pachana Medohara Raktashodhaka and Yakruta uttejaka actions Clinical research shows its effectiveness in reducing liver fat improving digestion and enhancing hepatic metabolism with no reported adverse effects

The present study is a randomized open label interventional clinical trial comparing Siravedhana with Sharapunkhadi Churna versus Sharapunkhadi Churna alone in NAFLD Grades 1 and 2 A total of 30 participants will be assessed over 45 days The intervention group will undergo six weekly Siravedhana sittings along with Sharapunkhadi Churna while the control group will receive only the herbal formulation Parameters such as USG grading lipid profile BMI and subjective symptoms will be evaluated The study aims to establish the therapeutic efficacy of integrating Siravedhana with herbal management as a minimal invasive cost effective Ayurvedic modality for early NAFLD

 

 

 
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