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CTRI Number  CTRI/2024/09/073613 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 13/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Physiotherapy (Not Including YOGA)
Other (Specify) [RAKTAMOKSHANA]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study between blood letting and physiotherapy exercise in management of back pain 
Scientific Title of Study   A comparative clinical study between Raktamokshana and Physiotherapy in management of Katigraha- A randomized comparative clinical trial 
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 Dhyankumar P Patel 
Designation  MS Scholar 2nd Year 
Affiliation  Shree swaminarayan ayurvedic college 
Address  Department of Shalya Tantra, Shree swaminarayan ayurvedic college, Swaminarayan university, Kalol.

Gandhinagar
GUJARAT
382725
India 
Phone  9687103205  
Fax    
Email  pateldhyan75@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anita Patel 
Designation  Professor 
Affiliation  Shree swaminarayan ayurvedic college 
Address  Department of Shalya Tantra, Shree swaminarayan ayurvedic college, Swaminarayan university, Kalol.

Gandhinagar
GUJARAT
382725
India 
Phone  9176945090  
Fax    
Email  dranitasudha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anita Patel 
Designation  Professor 
Affiliation  Shree swaminarayan ayurvedic college 
Address  Department of Shalya Tantra, Shree swaminarayan ayurvedic college, Swaminarayan university, Kalol.

Gandhinagar
GUJARAT
382725
India 
Phone  9176945090  
Fax    
Email  dranitasudha@gmail.com  
 
Source of Monetary or Material Support  
Shree Swaminarayan ayurvedic college,Kalol-382725, Gujarat, India.  
 
Primary Sponsor  
Name  Shree swaminarayan ayurvedic college 
Address  Department of Shalya Tantra, Shree swaminarayan ayurvedic college, Swaminarayan university, Kalol-382725. Gujarat, India. 
Type of Sponsor  Research institution and hospital 
 
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 Dhyankumar P Patel  Premswarupswami ayurvedic multispeciality hospital  Room no.006 Shalya Tantra OPD, Department of Shalya Tantra, Premswarupswami ayurvedic multispeciality hospital, Swaminarayan university, Kalol-382725.
Gandhinagar
GUJARAT 		 9687103205

pateldhyan75@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Shree Swaminarayan Ayurvedic College, Swaminarayan University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M545||Low back pain. Ayurveda Condition: KATIKATARUNA-MARMAVIDDHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रक्तमोक्षणम्/ शोणितस्रावः/ अस्रविस्रुतिः/शस्त्रà (Procedure Reference: Sushruta sutrastana jalaukavarchan adhyay, Procedure details: Application of modified Shringa Yantra on the diseased part after pricking of skin by using 24 no. needle. Site:Lumber region, Duration:Twice a month(15 days interval))
2Comparator Arm (Non Ayurveda)-PhysiotherapyFive physical physiotherapy 1. Quadruped(All fours) stretch 2. Unilateral knee to chest stretch 3. Hamstrings stretch in the doorway 4. Supine stretch 5. Bridging site: Lumber region, Duration: Once a day for 1 month
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients who are indicated (Yogya) for Raktamokshana.
Age between 18 to 40 years.
Subjects of either gender.
Patients suffering from symptoms of,
(Katisula)Pain in the Back region since 6 weeks
(Katistambha)Stiffness in the Back region since 6 weeks
Associated complaints,
(Akunchana prasaran pravrutti savedana)Restricted movement since 6 weeks
 
 
ExclusionCriteria 
Details  Patients who are contraindicated ( Ayogya) for Raktamokshana.
Uncontrolled other systemic disorders like Diabetes mellitus, Hypotension, etc.
Subjects with congenital anomalies of the back region like spina bifida, vertebral
stenosis, lumbarization, sacralization, lordosis, etc.
Neuromuscular diseases like Myasthenia gravis, Muscular dystrophy,
neuromyotonia, etc.
Patient of any neurological disorders like sciatica etc.
The patient also has osteoarthritis, osteoporosis, fracture, lumbar herniated disc, lumbar spinal stenosis, ankylosing spondylitis, etc.
Female with gynecological disorders like uterine dysfunction and endometriosis and female in menstrual period and menopause.
Patients suffering from serious blood disorders like Anemia & life-threatening diseases like HIV and HEPATITIS.
Tuberculosis
Malignancy
Pregnancy
RED FLAG warning signs require immediate or urgent evaluation,
Cauda equina syndrome-Saddle anesthesia, Motor deficit at multiple levels, Urinary retention, Fecal incontinence
Significant or progressive neurological deficits- Progressive motor weakness, Severe or incapacitating back or leg pain (e.g., requiring
hospitalization, precluding walking, or significantly limiting activities of daily living)
Cancer-History of cancer with new onset low back pain, Unexplained weight loss
Vertebral infection-Fever, IV drug use, Recent infection
Vertebral compression fracture or
fracture due to acute injury-History of osteoporosis, Use of corticosteroids, Older age
Inflammatory back pain- Morning stiffness lasting longer than 30 minutes (especially upon rising) in patients under age 40 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Katisula(Pain in the Back region)
Katistambha(Stiffness in the Back region)

 		 1 Month

 
 
Secondary Outcome  
Outcome  TimePoints 
Akunchana prasaran pravrutti savedana(Restricted movement)
 		 1 Month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/10/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   This study is an open-label randomized comparative clinical trial to evaluate the efficacy of Raktamokshana. A total 40 number of patients will be selected in the present study.  20-20 patients for each group. In trial group will do raktamokshna with modified shring yantra (cupping set) in the lumber region for twice a month (15 days interval) and its follow-up period is 2 months. In control group will do Physical physiotherapy in lumber region for once a day for 1 month and its follow-up period is 2 months. Clinical data obtained will be summarized at the end of the study. The conclusion will be made after the statistical analysis of the data. 
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