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CTRI Number  CTRI/2024/06/068426 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Comparison between efficacy of Cupping method and Shringa method in raktamokshana therapy]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Bloodletting Therapy Methods for Treating Low Back Pain Using Shirna and Cupping Techniques 
Scientific Title of Study   A comparative controlled clinical study to evaluate the effect of Raktamokshana by Shringa and cupping method in the management of Katishoola with special reference to low back pain. 
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 Vipul Ajitkumar Gangwal  
Designation  Assistant Professor 
Affiliation  Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College 
Address  Department of Panchakarma , block no 5,Yahswantrao Chavan Ayurvedic Medical college, Nipani - Bhalgaon, Cha.Sambhajinagar(Aurangabad)

Aurangabad
MAHARASHTRA
431007
India 
Phone  9028301108  
Fax    
Email  vdvipulgangwal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pankaj Prakash Tathed 
Designation  Assistant Professor 
Affiliation  APMs Ayurved Mahavidyalaya 
Address  Department of Paqnchakarma , Room no 5, APMs Ayurved Mahavidyalaya. Beside our lady high School, Near Sion Railway Station, Sion, Mumbai 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9867715592  
Fax    
Email  drpankajtathed@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pankaj Prakash Tathed 
Designation  Assistant Professor 
Affiliation  APMs Ayurved Mahavidyalaya 
Address  Department of Panchakarma, Room no 5, APMs Ayurved Mahavidyalaya. Beside our lady high School, Near Sion Railway Station, Sion, Mumbai 400022

Aurangabad
MAHARASHTRA
400022
India 
Phone  9867715592  
Fax    
Email  drpankajtathed@gmail.com  
 
Source of Monetary or Material Support  
Department of Panchakarma, block no 6,Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College,Nipani Bhalgao, Chh.Sambhajinagar-431007 
 
Primary Sponsor  
Name  Dr.Vipul Ajitkumar Gangwal 
Address  plot no 20, sector b, opposite maharashta hotel, Cidco N-4, Cha.Sambhajinagar(aurangabad) , maharashtra 
Type of Sponsor  Other [Principal Researcher] 
 
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 Vipul Ajitkumar Gangwal  Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College  Block no 5,Department of Panchakarma, Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College, behind Videocon company , nipani-bhalgaon, aurangabad(chh.sambhajinagar)
Aurangabad
MAHARASHTRA 		 9028301108

vdvipulgangwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
A.P.M.s Ayurvedic Mahavidyalaya Sion Mumbai  Approved 
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: Katishoola,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रक्तमोक्षणम्/ शोणितस्रावः/ अस्रविस्रुतिः/शस्त्रà (Procedure Reference: रक्तमोक्षणम्, Procedure details: Prepration of Rasnadi Gulika9 This is a yoga of Yoga Ratnaker, described in chapter Vata vyadhi Chikitsa and is specially given in case of Gradhrasi. It contains Rasna (leaves of Pluchea lanceoiata of Cornpositae family) 1 Pala and Guggulu (Oleo gum resin of Commiphora mukul of Burseraceae family) 5 Karsha that is Rasna 4 parts and Guggulu 5 parts, both are mixed together with the help of Ghrita and Pills will be made. रक्तमोक्षणम् Standard Operative p)
(1) Medicine Name: Rasnadi Guggulu, Reference: Dr.Radhey Sharma,Dr.Bharti Bandil, a clinical evaluation of rasnadi guggulu & katibasti in katishool (w.s.r. to lumbo-sacral disorder), NIA Jaipur, Thesis for Doctor of philosophy 2002, page no 52., Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 14 Days
2Comparator ArmProcedure-raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रक्तमोक्षणम्/ शोणितस्रावः/ अस्रविस्रुतिः/शस्त्रà Pradhan Karma(Procedure Reference: रक्तमोक्षणम्, Procedure details: रक्तमोक्षणम्/ शोणितस्रावः/ अस्रविस्रुतिः/शस्त्रविस्रावणम् Standard Operative procedure of Cupping therapy . For this clinical study Wet Cupping methodology will be used for Raktamokshana. Trividha Karma for Cupping therapy will be as follows Purvakarma 1. Written inform consent of the patient will be taken having the information regarding the procedure to the patient and relatives )
(1) Medicine Name: Rasnadi guguulu, Reference: Dr.Radhey Sharma,Dr.Bharti Bandil, a clinical evaluation of rasnadi guggulu & katibasti in katishool (w.s.r. to lumbo-sacral disorder), NIA Jaipur, Thesis for Doctor of philosophy 2002, page no 52, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 14 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients fulfilling the diagnostic criteria. • Duration not more than 6 weeks, • Patients of both gender aged between 16-70 years. • Irrespective of sex age education for all category and socieo-economical status. • Patient willing for trial and giving written consent. • Patient who will be comfortably able to complete the Raktamokshana in Sitting with elevated back and forward bending head or prone position. 
 
ExclusionCriteria 
Details  Known Case of Any systemic disorder or any serious illness, maligancny, infectious disease , congenital problem, hypertension , HIV positive , HbsAg positive or Covid 19 positive patients, Any known case of Neuroloigcal disorders.
• Patients who is pregnant will be excluded for Raktamokshana.
• Patients is having any history of cardiac disorder or on any blood thinner medicine or known case of any heamtological disorders. • Patient having Hemoglobin percentage less than 12 for women and less than 13 for men. • Age less than 16 and beyond 70 will not be included in studies. • Earlier went to the Cupping therapy or Shringa therapy or Cupping therapy. • Patients having associated diseases like Tuberculosis, Fractures, and other complications. • Patients having marked deformities of spinal column. Such as Sacralisation Spinal stenosis, Disturbed bowel-bladder control. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the comparative clinical efficacy of Raktamokshana by Shriga and Cupping method in the management of Katishoola with special reference to Low back pain.  10 months 
 
Secondary Outcome  
Outcome  TimePoints 
1) To evaluate the clinical efficacy of Raktamokshana by Shringa method in the management of Katishoola with special reference to low back pain.
 		 1 months 
2) To evaluate the clinical efficacy of Raktamokshana by Cupping method in the management of Katishoola with special reference to low back pain.  1 months 
3) To Compare clinical efficacy of Raktmokshana by Shringa and Cupping method in the management of Katishoola with special reference to low back pain.  1 months 
4) Study on Cupping method for Raktamokshana and possible establishment as comparing to Shringa method.  1 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 3 
Date of First Enrollment (India)   15/06/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

This study is Randomized controlled clinical study, trial conduction the comparative efficacy of Raktamokshana panchakarma therapy using two methodologies one is by cupping method and another is Shringa method. In which patient suffering from Low back pain who is the inclusion criteria will be involved in the study. 90 patients will be randomly divided in two groups in which each group will having 45 no of patients. Both group will received Rasnadi Guggulu in the form of tablet and dose will be 500mg twice a day for 14 days with Anupana  Koshna Jala (Luke warm water) through Oral route (Mouth).And In Group A and B  Raktmaokshana will be done On 0th day(Basline) On 7th day On 14th Day that is completion of trail for patients and then on 21st day after stating of trail again follow up study will be done. Assessment of Pain by VAS Scale will be done before procedure and after procedure on 0th ,7th day,14th day & on 21st day (1st follow up study), Assessment of Criteria Subjective & Objective Before treatment (B.T.) i.e. 0th day 7th day, 14th day (After treatment-A.T.) & on 21st day(1st follow up study) will be done. Primary and Secondary outcome will be observed and studied as soon as complete trail will be done.

 
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