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CTRI Number  CTRI/2025/03/083716 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 28/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Ethnic Marma Therapy and Wet Cupping Therapy in Grivasandhigata Vata w.s.r. to Cervical Spondylosis  
Scientific Title of Study   Efficacy of Ethnic Marma Therapy and Wet Cupping Therapy in Grivasandhigata Vata w.s.r. to Cervical Spondylosis – An open Labelled A Randomised 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  PAD PRABHA WEERANAYAKE 
Designation  PG STUDENT 
Affiliation  Institute of Teaching and Research in Ayurveda  
Address  Department of Shayla Tantra Institute of Teaching and Research in Ayurveda Jamnagar Gujarat 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  6356250957  
Fax    
Email  prabha.weeranayake@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr P B JOSHI 
Designation  Reader 
Affiliation  Institute of Teaching and Research in Ayurveda  
Address  Department of Shayla Tantra Institute of Teaching and Research in Ayurveda Jamnagar Gujarat 361008

Jamnagar
GUJARAT
361008
India 
Phone  9427226504  
Fax    
Email  pbj@itra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr P B JOSHI 
Designation  Reader 
Affiliation  Institute of Teaching and Research in Ayurveda  
Address  Department of Shayla Tantra Institute of Teaching and Research in Ayurveda Jamnagar Gujarat 361008

Jamnagar
GUJARAT
361008
India 
Phone  9427226504  
Fax    
Email  pbj@itra.edu.in  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda ,Jamnagar ,Gujarat,India 361008 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda Jamnagar  
Address  Institute of Teaching and Research in Ayurveda Jamnagar 361008 
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 Peduru Arachchige Don Prabha Weeranayake  Institute of Teaching and Research in Ayurveda  Institute of Teaching and Research in Ayurveda Department of Shayla Tantra OPD room112
Jamnagar
GUJARAT 
6356250957

prabha.weeranayake@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Institute of Teaching and Research in Ayurveda   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M472||Other spondylosis with radiculopathy. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAM (KEVALAVATA), (2) ICD-10 Condition:M488||Other specified spondylopathies. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-Wet Cupping (Procedure Reference: , Procedure details: 1.Informed written consent will be taken from all patients 2. Before 1h of procedure, the patient will be advised to have Mudgayusha 3. Local Abhayang & Nadi swedana will be done prior to procedure 4. During the therapy, therapist has to continuously watch the facial expressions of the patient 5. Vitals should be checked before & after the therapy. 2. Procedure: 1. In the sitting position (semi-flexed neck), cups will be applied on the most painful points, & a negative pressure will created & maintained for 3–5 min. 2. Then, the cups will be released. Incisions will be made on the site by acupuncture needles of demarcated area of cups. Then, the cups will be reapplied on incision marked area, & negative pressure will be created)
2Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Susrutha sareera chapter 06, Procedure details: The Marma Stimulation will be given at affected area of upper extremity 1.​Krikatika Marma 2.​Kshipra Marma 3.​Kurpara Marma 4.​Ani Marma 5.​Urvi Marma 6.​Ansa Marma Each Marma will be stimulated 3-5 times in the same rhythm of inhale & exhale by digital pressure in one sitting. The rhythm of stimulation is same as the rhythm of respiration ,18 to 20 times per minute. The facial expression of the patient should be observed for pain, vertigo & fainting. Each Marma point will be pressed for 20 times. Thus, one session of Marma Therapy will be carried out during the morning time. Once daily for 2 weeks)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Diagnosed patients of Grivasandhi gate vats (cervical spondylosis) within the age group 20-60 years will be enrolled irrespective irrespective of sex , religion, occupation , socioeconomic status etc.
2.Patients who who are compulsory with Grivasandhi shoola ( cervical pain ) & Grivasandhi Stambha ( stiffness in cervical region).
3. Patients including Grivasandhi shoola & Grivasandhi Stambha & none of Grivasandhi shopha & Prasaran Akunchana Pavritti 
 
ExclusionCriteria 
Details  1. Age below 20 years and above 60 years.
2. Patients with uncontrolled diabetes (RBS greater than 140mg/dl) and uncontrolled hypertension (BP greater than 160/90mmHg)
3. Tuberculosis of cervical spine & malignancy.
4. Patients with cervical rib, Fracture of Cervical Spine.
5. Other diseases like cardiac diseases, renal diseases and endocrine diseases, and severe Anaemia and immunosuppressive disorders, Serology Positive patients.
6. Pregnant and lactating women. 
 
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 
1.Relief in pain and stiffness of Cervical Spondylosis.
2.Painless increased Angle to of the Movement ( AOM). 
4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Cost effective
• Time saving
• Minimum facilities required
• Minimize side effects
• Non pharmacological 
4 weeks  
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   23/06/2025 
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 - NO
Brief Summary  
Cervical spondylosis is the progressive degeneration at intervertebral disc, which is a common complaint in ageing population. It presents commonly with either neck or back pain. Cervical Spondylosis develops as a result of the wear & tear of the cartilage & bones of the neck. It leads to pain & stiffness in the neck, radiating pain in the arm, headache, weakness, tingling in the neck, numbness symptomatic compression of the spinal cord (myelopathy), nerve roots (radiculopathy), or problems with bladder function from cervical myelopathy.  They  present  as  spondylosis  and  inflict  damage  to cervical  spine  in  men  as early  as  20 years  and  in females at the age of 30 years.Griva Sandhigata Vata (Manyastambha ) is a clinical condition in which structural as well as functional disarrangement takes place in the joint of the neck. It can be identified as a disease of Sandhi (joint) with the symptom of Sandhi Shoola, Sandhishopha, Asthi Shosh and Bheda and Vaatpurnadruti Sparsha, Shotha Akunchana, Prasarana, Pravritti Savedana. Vitiation of Vata as a result of Dhatukshaya is generally considered the causative factor of this disease. It can be correlated with Cervical Spondylosis. In the Ayurveda text, Griva SandhigataVata can be treated with Agnikarma, Upnaha, Bandhan, Snehana, Mardan, Basti, etc. Marma are vital points where two or more types of tissue meet, such as muscles, veins, ligaments, bones or joints. These points range in size from one to six inches in diameter. The points were mapped out in detail centuries ago in the  Sushruta Samhita , a classic Ayurvedic text. In Marma therapy, a very light stimulation of points on the body is done. It removes blockages from the Marma points giving physical and psychological relaxation and strength. This is a powerful process and a therapy that works with these subtle and sensitive energy points to open the energy channels in the body are called srotas. So, Marma points, when gently pressed on the skin can stimulate a chain of positive events. Wet cupping, a regimental modality, has been used in the treatment of joint pain and many other conditions since antiquity in Unani medicine. It is the modification of Shrung type of Raktamokshan (bloodletting). It relieves the pain and other related symptoms by diverting and evacuating the causative pathological humours. Ethnic Marma Therapy had emerged as a new dimension in non-pharmacological treatment of Ayurveda. So it minimizesthe side effect of drugs in old patients. The Kshipra, Kurpara, Ani, Urvi, and Amsa of upper limb Marma chikitsa can be used to alleviate the radiculopathic pain of Cervical Spondylosis as well as it has the potential to re-establish the cervical spine physiology.  Ethnic Marma Therapy had emerged as a new dimension in non-pharmacological treatment of Ayurveda. So, it minimizesthe side effect of drugs in old patients. The Kshipra, Kurpara, Ani, Urvi, and Amsa of upper limb Marma chikitsa can be used to alleviate the radiculopathic pain of Cervical Spondylosis as well as it has the potential to re-establish the cervical spine physiology.Wet cupping therapy has been very well-known treatment modality for Cervical Spondylosis management. Cupping therapy is a simple, safe, tolerable, effective, economic and time-saving treatment. It is already mentioned in classic under Rakthamokshana Therapy Both Wet Cupping therapy and Marma Therapy are effective in the management of Cervical Spondylosis. To compare the most effective therapya comparative trial is conducted with Marma Therapy against the wet Cupping Therapy in the management of Cervical Spondylosis. Also comparing Marma Therapy is non-invasive treatment procedure but WetCupping Therapy proved on as invasive treatment procedure with bleeding skin rashes increase pain and discomfort.    Hence this study 30 diagnosed cases of Grivasandhi gata vata shall be selected from OPD and IPD of I.TR.A. Hospital Jamnagar .The enrolled patients will be randomly allocated into two arms.Intervention arm: will be treated by Wet Cupping Therapy once a week in two weeks 2 sittings and comparator arm will be treated with Marma for once a day in two weeks 14 sittings.Parameters such as pain,stiffness,movement of the neck by Gonio meter and marked on specially designed research proforma.Follow up will be taken after 1 month after completion of treatment.The data generated during the present study will be presented in a systematic manner and shall be analysed statistically.The important points of the conceptual study,analytical study will be discussed.
 
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