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CTRI Number  CTRI/2024/11/076619 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Evaluate the effect of Raktamokshana - Blood letting in patients of Acute inflammation 
Scientific Title of Study   Randomised controlled clinical trial to evaluate the efficacy of raktamokshana using siravedha in vranashotha w.s.r. to acute inflammatory diseases 
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 Yogesh Shankarrao Borase 
Designation  Ph.D. Scholar 
Affiliation  Ayurved Seva Sanghs, Ayurved Mahavidyalaya 
Address  Department of Shalyatantra Ayurved Seva Sanghs, Ayurved Mahavidyalaya, Ganeshwadi, Panchavati, Nashik Tal. Nashik, Dist. Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  8329008455  
Fax    
Email  dryogeshborase@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinay Sonambekar 
Designation  Professor & HOD Shalyatantra 
Affiliation  Ayurved Seva Sanghs, Ayurved Mahavidyalaya 
Address  Department of Shalyatantra, Ayurved Seva Sanghs, Ayurved Mahavidyalaya, Ganeshwadi, Panchavati, Nashik Tal. Nashik, Dist. Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  9822624890  
Fax    
Email  sonambekar.chinmay@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Yogesh Shankarrao Borase 
Designation  Ph.D. Scholar 
Affiliation  Ayurved Seva Sanghs, Ayurved Mahavidyalaya 
Address  Department of Shalyatantra, Ayurved Seva Sanghs, Ayurved Mahavidyalaya, Ganeshwadi, Panchavati, Nashik Tal. Nashik, Dist. Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  8329008455  
Fax    
Email  dryogeshborase@gmail.com  
 
Source of Monetary or Material Support  
Ayurved Seva Sanghs, Ayurved Mahavidyalaya, Ayurved Seva Sanghs, Ayurved Mahavidyalaya, Ganeshwadi, Panchavati, Nashik Tal. Nashik, Dist. Nashik, Pin-422003, State - Maharashtra, Country -India 
 
Primary Sponsor  
Name  Dr Yogesh Shankarrao Borase 
Address  Ayurved Seva Sanghs, Ayurved Mahavidyalaya, Ganeshwadi, Panchavati, Nashik Tal. Nashik, Dist. Nashik, Pin-422003, Maharashtra, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinay Sonambekar  Ayurved Seva Sanghs, Arogyashala Rugnalaya, Ganeshwadi, Panchavati, Nashik  Ayurved Seva Sanghs, Ayurved Mahavidyalaya, Department of Shalyatantra, Ganeshwadi, Panchavati, Nashik Tal. Nashik, Dist. Nashik, Pin-422003, Maharashtra, India
Nashik
MAHARASHTRA 		 9822624890

sonambekar.chinmay@gmail.com 
Dr Yogesh Shankarrao Borase  MES Ayurved Mahavidyalayas Parshuram Hospital & Research Center  MES Ayurved Mahavidyalaya, Department of Shalyatantra, Ghanekhunt-Lote, Tal- Khed, Dist-Ratnagiri, PIN-415722
Ratnagiri
MAHARASHTRA 		 8329008455

dryogeshborase@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee, Ayurved Seva Sanghs, Ayurved Mahavidyalaya, Nashik  Approved 
MESAM Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VRANASOPAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: Sushrut Samhita Chikitsasthan / Dr. Anatram Sharma / Chaukhambha Surabharati Prakashan, Varanasi, 2017 / 1st chapter / Shloka no. 27-28/ Page no. 158, Procedure details: Raktamokshana - Bloodletting using Siravedh from nearby vein of the inflamed part of body as indicated in sushrut samhita Quantity of Raktamokshana - 60 ml twice on 1st day & 4th day Eqipments for Raktamokshana - Disposable Needle No. 16, 18, 20 & Scalp vain set Dressing Material as per requirement)
(1) Medicine Name: Amoxicillin & Clavulonic Acid, Reference: Modern Medicine, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 625(mg), Frequency: bd, Duration: 5 Days
(2) Medicine Name: Diclomol SP, Reference: Modern Medicine, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 60(mg), Frequency: bd, Duration: 5 Days
2Comparator Arm (Non Ayurveda)-Control Group(1) Medicine Name: Amoxicillin & Clavulonic Acid, Reference: Modern Medicine, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 625(mg), Frequency: bd, Duration: 5 Days (2) Medicine Name: Diclomol SP, Reference: Modern Medicine, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 60(mg), Frequency: bd, Duration: 5 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having signs and symptoms of Vranashotha (Acute Inflammation)
 
 
ExclusionCriteria 
Details  1. Patients of the age below 18 yrs & above 60 yrs
2. Patient who has taken Vaman, Virechan or Niruhbasti
3. Patients having bleeding disorders like Haemophilia Purpura etc.
4. Patient having high grade fever, breathing difficulties & cough
5. Patient of Tuberculosis, Epileptic episodes & Unconsciousness
6. Seriously ill patients with General debility, Generalized body oedema
7. Patient having HTN, DM, Malignancy or Renal Failure
8. Patient with HBsAG or HIV positive.
9. Patient in their ANC and Lactation period.
10. Patient not willing to give consent for the treatment.
11. Patient with infective pathology of more than 7 days. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the add on efficacy of Raktamokshana using Siravedha in reducing the
clinical features of Vranashotha w.s.r. to Acute inflammatory diseases. 		 enrolment day, 4th day, 7th day, 10th day 
 
Secondary Outcome  
Outcome  TimePoints 
1) To study about clinical & pathological changes after Raktamokshana using
Siravedha in Vranashotha w.s.r. to Acute inflammatory diseases.
2) Literary review of Raktamokshana & Vranashotha
 		 1) Clinical & pathological changesat 4th day,7th day & 10th day
2) Literary review of Raktamokshana & Vranashotha during study period
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/11/2024 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dryogeshborase@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   TITLE :- RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF RAKTAMOKSHANA USING SIRAVEDHA IN VRANASHOTHA W.S.R. TO ACUTE INFLAMMATORY DISEASES
INTRODUCTION :- Shalyatantra is a branch of Ayurveda which was specialised & developed by Acharya Sushruta known as father of surgery who has elaborated various surgical & parasurgical procedures in the precious grantha Sushrut Samhita. Rakta is considered as fourth dosha in addition to Tridoshas by Acharya Sushruta1 & Raktamokshana is described as one of the parasurgical procedure which has given prime importance & considered as half part of the treatment in surgical diseases as that of Bastichikitsa in medical diseses2 . Raktamokshana is further classified in two types Shastrakruta & Ashastrakruta3 . Siravedha & Pracchan comes under Shastrakruta Raktamokshana while Jalaukavacharan, Shringa & Alabu are included in Ashastrakrut Raktamokshana4 . Siravedha type of Raktamokshana is indicated specifically to evacuate deep seated impurities in the body which occurs due to vitated tridoshaj5 . Vranashotha is a condition which occurs in many diseses due to vitated tridoshaj due to internal metabolic disturbances or external factors like hazardous microbes, insect toxins, chemicals, heat, physical trauma etc. Vranashotha is a localised swelling affecting Twacha & Maans which can occur in any body part due to accumulation of vitated doshaj6 . Acute inflammation is a short duration process occurring in response to tissue injury, usually appearing within minutes or hours7 .It is characterized by five cardinal signs: pain, redness, swelling, Rise in temperature & loss of functions of the affected tissues8 . C- Reactive protein, ESR & Plasma viscosity are the blood tests considered as inflammatory markers for the evaluation & prognosis of acute inflammatory diseases9 . Among the three stages of Vranashotha first stage is Amavastha10 which can be considered as acute inflammatory stage is indicated for Avasechan11 among the seven procedures in the treatment of Vranashotha. Avasechan can be considered as Page 2 of 29 Raktavsechan which is indicated for pain relief & to avoid further suppurative changes in Amavastha of Shotha i.e. acute inflammation12 . Previously researches are conducted on the efficacy of Jalaukavacharana & lepan chikitsa on Vranashotha. Previously no researches are found on the efficacy of Siravedha in Vranashotha. These procedures are more time consuming than siravedha. Also some patients are anxious about Jalauka & excessive bleeding may occur after Jalaukavacharan. Some adverse effects on skin may occur due to lepas. Due to Vranashotha i.e. inflammatory pathology Sthanik (loclised inflammation) as well as Sarvadaihik Raktadushti (increased WBC count & CRP levels) occurs. Siravedha is indicated for Sarvadaihik Raktadushti. In day to day practice number of patients having acute inflammatory pathology is noticeable & requires immediate attention to avoid further complications. Hence considering the correlation of Vranashotha with Acute inflammation & indication of Raktamokshana in Vranashotha i.e. Acute Inflammatory Conditions the topic RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF RAKTAMOKSHANA USING SIRAVEDHA IN VRANASHOTHA W.S.R. TO ACUTE INFLAMMATORY DISEASES is selected for the study. 
RESEARCH QUESTION :- Is Raktamokshana using Siravedha effective in reducing the clinical features of Vranashotha w.s.r. to Acute inflammatory diseases? 
HYPOTHESIS :- 
H0 - Raktamokshana using Siravedha is not effective in reducing the clinical features of Vranashotha w.s.r. to Acute inflammatory diseases. 
H1 - Raktamokshana using Siravedha is effective in reducing the clinical features of Vranashotha w.s.r. to Acute inflammatory diseases
AIM :- To Evaluate the add on efficacy of Raktamokshana using Siravedha in reducing the clinical features of Vranashotha w.s.r. to Acute Inflammatory Diseases. 
OBJECTIVES :- 1) To study the add on efficacy of Raktamokshana using Siravedha in reducing the clinical features of Vranashotha w.s.r. to Acute inflammatory diseases. 
2) To study about clinical & pathological changes after Raktamokshana using Siravedha in Vranashotha w.s.r. to Acute inflammatory diseases. 
3) Literary review of Raktamokshana & Vranashotha 
STUDY DESIGN :- Randomized Controlled Clinical Trial. 
SAMPLING TECHNIQUE :- Simple Randomized Sampling.(Lottery Method) 
SAMPLE AREA :- Patients coming in OPD and IPD of Shalyatantra department of our hospital with classical signs and symptoms of Vranshotha i.e. Acute Inflammatory Diseases. 
SAMPLE SIZE :-100 Patients will be randomly selected and equally distributed in two groups. i.e 50 Patients in each group - A) Trial Group & B)Control Group
STUDY LOCATION :- Opd and Ipd of Shalyatantra department of Research Center & Currently Employed Ayurveda College 
FOLLOW UP :- At 0th day, 4th day, 7th day & 10th day 
CONSENT: A well-informed written consent will be taken from all the patients included in the study before starting the treatment  
Treatment Plan :- 
A) Trial Group - Raktamokshana using Siravedha 60 ml twice on 1st day & 4th day Tab. Amoxicillin 500 mg + Clavulanic Acid 125 mg 1 Bid for 5 days; Tab. Diclomol SP 1 Bid for 5 days
B) Control Group - Tab. Amoxicillin 500 mg + Clavulanic Acid 125 mg 1 Bid for 5 days; Tab. Diclomol SP 1 Bid for 5 days
ASSESSMENT CRITERIA:- 
A) Objective Parameters :- 
1. CRP value - Before & After treatment 
2. WBC Count - Before & After treatment 
3. Neutrophill Count - Before & After treatment
B) Subjective Parameters :- 1. Dolar (pain & tenderness) - VAS scale; 2. Rubor (Redness/ Erythema) ; 3. Tumor (swelling); 4. Calor (Rise in local temperature ) ; 5. Loss of functions ; 6. Induration
DATA COLLETION TOOLS : 
Case record form in OPD and IPD Ayurvedic Samhita, Ayurvedic textbooks Modern textbooks Investigations Review of literature Concerned material review from Articles & Books Information from Internet sources. 
METHODS FOR DATA COLLECTION RELEVANT TO OBJECTIVES: 
A) Total patients who are having Vranshotha (Acute Inflammation) will be selected from study area irrespective of age, sex, religion, education, occupation, diet. B) Case record form.
DATA MANAGEMENT AND ANALYSIS PROCEDURE: All information collected from a clinical study will be recorded in M.S. Excel Sheet and presented in the form of Graphs, Charts and Tables. 
DATA ANALYSIS PLAN AND METHODS : 1) All information collected from a clinical study will be presented in the form of Graphs, Charts and Tables. 2) All the observed data will be analyzed and suitable statistical tests will be applied. 
 
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