CTRI

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CTRI Number

CTRI/2025/07/092084 [Registered on: 31/07/2025] Trial Registered Prospectively

Last Modified On:

31/07/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Single Arm Study

Public Title of Study

A study to know the effect of raktamokshana (blood letting) with shrunga yantra (cupping) in managing pain in vishwachi or cervical spondylosis

Scientific Title of Study

A CLINICAL STUDY TO EVALUATE THE EFFECT OF RAKTAMOKSHANA WITH MODIFIED SHRUNGA YANTRA ( CUPPING ) IN MANAGEMENT OF VISHWACHI W.S.R TO CERVICAL SPONDYLOSIS

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 Rahul Aari
Designation	Post graduate scholar
Affiliation	Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital & Research Centre
Address	Department of pg studies in Shalya tantra, Sri dharmasthala manjunatheshwara college of Ayurveda Hospital & research Centre, Kuthpady, Udupi Udupi KARNATAKA 574118 India
Phone	7892182127
Fax
Email	drrahulaari1808@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Rajneesh V Giri
Designation	Professor and head of department
Affiliation	Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital & Research Centre
Address	Department of pg studies in Shalya tantra, Sri dharmasthala manjunatheshwara college of Ayurveda Hospital & research Centre, Kuthpady, Udupi Udupi KARNATAKA 574118 India
Phone	9845407543
Fax
Email	drrajneeshgiri@gmail.com

Details of Contact Person
Public Query

Name	Dr Rahul Aari
Designation	Post graduate scholar
Affiliation	Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital & Research Centre
Address	Department of pg studies in Shalya tantra, Sri dharmasthala manjunatheshwara college of Ayurveda Hospital & research Centre, Kuthpady, Udupi Udupi KARNATAKA 574118 India
Phone	7892182127
Fax
Email	drrahulaari1808@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Dr Rahul Aari
Address	Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital & Research Centre Kuthpady Udupi 574118 Karnataka India
Type of Sponsor	Other [self]

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 Rahul Aari	Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital & Research Centre	Department of Shalya Tantra Sri Dharmasthala manjunatheshwara college of ayurveda kuthpady Udupi Udupi KARNATAKA	7892182127 drrahulaari1808@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
SriDharmasthala Manjunatheshwara College of Ayurveda Institutional ethical commitee	No Objection Certificate

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Procedure	-	GaTiyantrAvacaraNam, घटियन्त्रावचरणम्	(Procedure Reference: Reference: Sushrutha samhita of sushrutha sharirastana siravyadhavidhi adhyaya chapter 8 verse 17 varanasi choukamba surbharati prakashan 2003 380, Procedure details: purvakarma consent of the patient is taken after explaining the procedure vitals will be checked & recorded after proper examination tender point will be marked Modified shrunga yantra(cups) of appropriate size depending in the site of maximum tenderness will be taken & cleaned by gauze using spirit Pradhanakarma Site of maximum tenderness which is marked is cleaned with spirit 8 to 10 superficial pricks will be done on marked areawith the help of disposable sterile needle number 18 The modified shrunga yantra(cups) will be placed & vacuum will be created on the marked area for complete oozing of blood & till the blood clots The amount of blood collected will be noted & the area will be cleaned with sterile gauze dipped in spirit Paschatkarma Normal saline will be used to clean the region haridra choorna will be sprinkled & hemostasis will be monitored Duration Two sittings gap duration between two sittings is 7 days)

Inclusion Criteria

Age From	25.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patients with features of vishwachi like radiating pain from prishta(back), skandha(shoulder), bahu(arm), karpura(elbow), extending up to hasta talam(palm) and pratyanguli( fingers) stambha(stiffness), toda(pricking pain) of neck, tingling, numbness and difficulty in movements of hands or patients with positive spurlings test or patients with positive neck flexion and extention compression test or patients with positive neck distraction test or patients with positive lhermittes sign

ExclusionCriteria

Details

Patients contraindicated for raktamokshana, patients with history of uncontrolled diabetes mellitus( HBA1c level of greater than 7% to greater than 8%) and hypertension( systolic bp greater than or equal to 140mmhg and diastolic bp greater than or equal to 90mmhg)
patients with spinal fractures, having associated conditions like ankylosing spondylitis, spondylolisthesis. Patients with spinal tuberculosis, neoplasms in and around the spine or cervical region, patients with rheumatoid arthritis and patients with clinical presentation other than cervical spondylosis

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
pain reduction and other symptoms of vishwachi ( cervical spondylosis)	first day post procedure

Secondary Outcome

Outcome	TimePoints
reduction in pain and other symptoms of vishwachi (cervical spondylosis)	seventh day and fourteenth day post procedure

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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

N/A

Date of First Enrollment (India)

11/08/2025

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)

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 - YES

What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiﬁcation.

What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Who will be able to view these files?
Response - Anyone

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

By what mechanism will data be made available?
Response (Others) - data can be collected from sdm college of ayurveda hospital and research centre kuthpady udupi

For how long will this data be available start date provided 04-01-2026 and end date provided 04-01-2030?
Response - Immediately following publication. No end date.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL

Brief Summary

Title: A Clinical Study to Evaluate the Effect of Raktamokshana with Modified Shrunga Yantra (Cupping) in the Management of Vishwachi with Special Reference to Cervical Spondylosis

Candidate: Dr. Rahul Suresh Aari 1st Year M.S. (Ayu) PG Scholar, Department of PG Studies in Shalya Tantra, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi, Karnataka.

Guide Dr. Rajneesh V. Giri, M.S. (Ayu), PhD, HOD and Professor, Department of PG Studies in Shalya Tantra.

Co-Guide Dr. Subhas Bhakta, M.S. (Ayu), Assistant Professor, Department of PG Studies in Shalya Tantra.

Institution Sri Dharmasthala Manjunatheshwara College of Ayurveda, Udupi, Karnataka.

Submission Date October 16, 2023

Objective To evaluate the efficacy of Raktamokshana using modified Shrunga Yantra (cupping therapy) in managing Vishwachi, correlated with cervical spondylosis.

Background and Need for Study

Cervical Spondylosis A degenerative condition affecting the cervical spine, common from the third decade, peaking in the fifth and sixth decades. Symptoms include chronic neck pain, stiffness, radiating pain, and paraesthesia, resembling Vishwachi, a Vata-related disorder in Ayurveda affecting the neck and upper limbs.

Vishwachi Characterized by symptoms like pain (Ruk), pricking pain (Toda), stiffness (Stambha), and weakness in the upper limbs, caused by vitiated Vata and Rakta doshas.

Current Treatments Conventional treatments include physiotherapy, analgesics, steroids, and surgery, which may have side effects like musculoskeletal and metabolic issues. Raktamokshana, a para surgical Ayurvedic procedure, is indicated for Vishwachi due to its minimal complications and cost-effectiveness.

Literature Review

Vishwachi is described in Ayurvedic texts as a Vata disorder affecting the neck, shoulder, and arms, correlating with cervical spondylosis, which involves degenerative changes in cervical vertebrae (C5C6, C6C7, C4C5).

Raktamokshana by Siravyadha is a recommended treatment for Vishwachi in classical texts.

Previous studies showed that Shringavacharana (cupping) provided steady symptom relief, while Agnikarma offered quicker but less sustained results.

Hypothesis

Null Hypothesis Raktamokshana with modified Shrunga Yantra has no significant effect on Vishwachi.

Alternative Hypothesis Raktamokshana with modified Shrunga Yantra has a significant effect on Vishwachi.

Methodology

Study Design Open-label clinical study with pre and post test design.

Sample Size Minimum of 30 patients aged 25 to 70 years diagnosed with Vishwachi cervical spondylosis from SDM Ayurveda Hospital, Udupi.

Diagnostic Criteria Neck pain, stiffness, radiating pain, paraesthesia, positive Spurlings test, neck compression extension tests, Lhermittes sign, and Xray findings.

Inclusion Criteria Patients with Vishwachi symptoms, aged 25 to 70 years, with written consent.

Exclusion Criteria Patients contraindicated for Raktamokshana, with uncontrolled diabetes (HbA1c more than7 ), hypertension (BP greater than or equal to 140 by 90 mmHg), spinal fractures, or conditions like ankylosing spondylitis, tuberculosis, or neoplasms.

Intervention: Two sittings of Raktamokshana using modified Shrunga Yantra (cupping) with 7 day intervals. Procedure involves marking tender points, making superficial pricks with a sterile needle, applying cups to create a vacuum, and cleaning the site post-procedure. Patients advised to avoid strenuous activities and certain foods for a day.

Study Duration 14 days with observations on days 1, 7, and 14, and follow up on day 14.

Assessment Criteria

Subjective Stiffness, Visual Analog Scale (VAS) for pain.

Objective Northwick Park Neck Pain Questionnaire, cervical range of motion (goniometer), Douleur Neuropathique 4 (DN4) for neuropathic pain.

Statistical Analysis Paired T test for parametric data and Wilcoxon signed rank test for nonparametric data.

Investigations Hb, TC, DC, ESR, CT, BT, HbA1c, HBsAg, HIV, Xray (AP lateral cervical spine), and CT spine if needed.

Ethical Considerations Ethical clearance obtained from the institutions ethical committee. The study involves human subjects, with no animal experiments.

References Includes Ayurvedic texts (Susrutha Samhita, Charaka Samhita), modern medical texts (example Harrisons Principles of Internal Medicine), and prior theses on related topics.

This study aims to provide evidence for the efficacy of Raktamokshana with modified Shrunga Yantra as a safe and effective treatment for Vishwachi cervical spondylosis, potentially offering an alternative to conventional treatments with fewer side effects.