| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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.)
| | 2 | Comparator Arm | Drug | Classical | | (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
|