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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | 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)
| 2 | Intervention Arm | Procedure | - | 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. |