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CTRI Number  CTRI/2021/04/032983 [Registered on: 20/04/2021] Trial Registered Prospectively
Last Modified On: 28/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effect of two therapies - Marma Chikitsa and Conventional Physiotherapy in patients with Cervical Spondylosis. 
Scientific Title of Study   A Clinical evaluation of Marma Chikitsa and Conventional Physiotherapy in the management of Grivasandhigata Vata w.s.r. to Cervical Spondylosis - A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR HIRENKUMAR BALVANTBHAI MISTRY 
Designation  PH.D. AYU SHALYA SCHOLAR 
Affiliation  INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA (INSTITUTE OF NATIONAL IMPORTANCE), JAMNAGAR 
Address  INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA (INSTITUTE OF NATIONAL IMPORTANCE), MINISTRY OF AYURVEDA, GOVERNMENT OF INDIA JAMNAGAR - 361008
DEPARTMENT OF SHALYATANTRA, OPD NO. 1 (SHALYA) & 2 (ASTHI MARMA), ITRA, JAMNAGAR
Jamnagar
GUJARAT
361008
India 
Phone  9427637420  
Fax    
Email  drhirenmistry@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR T S DUDHAMAL 
Designation  MS AYU PHD 
Affiliation  INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA (INSTITUTE OF NATIONAL IMPORTANCE), JAMNAGAR 
Address  INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA (INSTITUTE OF NATIONAL IMPORTANCE), MINISTRY OF AYURVEDA, GOVERNMENT OF INDIA JAMNAGAR - 361008
Department of Shalya Tantra, OPD no. 1 (Shalya) & 2 (Asthi-Marma) ITRA Hospital, Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax    
Email  drtsdudhamal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR T S DUDHAMAL 
Designation  MS AYU PHD 
Affiliation  INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA (INSTITUTE OF NATIONAL IMPORTANCE), JAMNAGAR 
Address  INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA (INSTITUTE OF NATIONAL IMPORTANCE), MINISTRY OF AYURVEDA, GOVERNMENT OF INDIA JAMNAGAR - 361008
Department of Shalya Tantra, OPD no. 1 (Shalya) & 2 (Asthi-Marma) ITRA Hospital, Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9428671939  
Fax    
Email  drtsdudhamal@gmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching & Research in Ayurveda, Jamnagar 
 
Primary Sponsor  
Name  DR HIRENKUMAR BALVANTBHAI MISTRY 
Address  INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA (INSTITUTE OF NATIONAL IMPORTANCE),MINISTRY OF AYUSH, GOVERNMENT OF INDIA, JAMNAGAR - 361008 
Type of Sponsor  Other [ITRA, Jamnagar] 
 
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 HIREN B MISTRY  INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA (INSTITUTE OF NATIONAL IMPORTANCE), JAMNAGAR  INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA (INSTITUTE OF NATIONAL IMPORTANCE), GURUDWARA ROAD, NEAR BANK OF INDIA, JAMNAGAR -361008
Jamnagar
GUJARAT 
9427637420

drhirenmistry@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE OF TEACHING AND RESEARCH IN AYURVEDA - IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M452||Ankylosing spondylitis of cervicalregion. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Marma Chikitsa   The Marma Chikitsa will be given in both Upper limb Marmas – 1. Kshipra Marma 2. Kurpara Marma 3. Ani Marma 4. Urvi Marma 5. Ansa Marma Each Marma point will be pressed for 18 to 20 times superficially on skin part. Thus, one session of Marma Chikitsa will be administered during the morning between 6 to 7 am. After giving pressure, the site will be rubbed gently to avoid the creation of a mark at the site. Duration : Two weeks Follow up period : One month  
Comparator Agent  Physiotherapy   Type : 1. Isometric exercises 2. Stretching exercises (Passive) 3. Mechanical Cervical traction (twice in a week) Time of therapy : 10 repetition of each exercises once a day Duration : Two weeks Follow up period: One month  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients suffering from Grivasandhigata Vata (Pain, Stiffness in cervical region or upper arm and Restricted range of motion of Cervical region (ROM))
2.Duration of Cervical Spondylosis upto 6 months
3.Patients with controlled diabetes mellitus
(FBS: <140mg/dl, PPBS :< 180mg/dl).
4.Patients with controlled Hypertension (BP <140mmHg)
5.Patients willing to undergo trial.
 
 
ExclusionCriteria 
Details  1.Age below 25 years and above 65 years.
2.Not willing to undergo trial
3.If Pain VAS score > 5
4.Tuberculosis of cervical spine & malignancy
5.Fracture related to cervical spine, significant
radiculopathy.
6.Other diseases like cardiac diseases, renal diseases and
endocrine diseases, severe Anemia, and Malignancy,
7.Patients of uncontrolled Diabetes mellitus
(FBS: >140mg/dl, PPBS:>180mg/dl)
8.Patients with uncontrolled Hypertension (BP >140mmHg)
9.Pregnant female.
 
 
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 
Subjective criteria:
The following symptoms will be assessed on the basis of gradation.
Grivasandhi Shoola (cervical pain)
Grivasandhi Stambha (Stiffness in cervical region)
Prasarana Akunchana Pravritti Savedana (painful movement of cervical)
Associate symptoms:
Headache
Giddiness
Tingling sensation
Loss of sensation
 
The progress will be noted in the specially prepared Clinical Research Performa (CRF). The observations will be analyzed on the basis of assessment parameters (Subjective and Objective) critically and clinically on 1st day, 7th day and 14th day.

 
 
Secondary Outcome  
Outcome  TimePoints 
Objective criteria:

Range of movement (ROM) will be measured with Goniometer.
1)Flexion (normally 50 degree)
2)Extension: (normally 80 degree)
3)Right / left Laretal flexion (normally 45 degree)
4)Right / left Lateral rotation (normally 85 degree)

Neck Disability Index (Vernon & Mior cervical spine score)
 
The progress will be noted in the specially prepared Clinical Research Performa (CRF). The observations will be analyzed on the basis of assessment parameters (Subjective and Objective) critically and clinically on 1st day, 7th day and 14th day.

 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "168"
Final Enrollment numbers achieved (India)="168" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2021 
Date of Study Completion (India) 11/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Marma Chikitsa to Manage Griva Sandhigata Vata W.S.R. to Cervical Spondylosis – A Case Study IJIM.,2023;4(2):1-10  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The research study entitled “A clinical evaluation of Marma Chikitsa & Conventional Physiotherapy in the management of Grivasandhigata Vata w.s.r to Cervical Spondylosis – A Randomized Controlled Trial” was aimed to evaluate and compare the efficacy of Marma Chikitsa & Conventional Physiotherapy in the management of Grivasandhigata Vata w.s.r to Cervical Spondylosis. This trial was summarized in review of literature, including Ayurvedic literature and modern literature of Grivasandhigata Vata (Cervical Spondylosis) and literature of Marma Chikitsa.

Clinical study stats the open labelled comparative clinical study of 168 clinical cases of Cervical Spondylosis divided into two groups according computer-generated randomization chart. Total 180 cases were screened throughout the study with cervical or neck pain, among which total 168 cases were falling in the study criteria. 06 cases were dropped out and 162 cases completed the course of treatment and follow up as mentioned in study. In Group-A (n=94): One session of Marma Chikitsa was given in morning hours for the period of 14 days. In Group-B (n=71):  Physiotherapy – Isometric and stretching exercise -10 repetition of each exercise in a day for 14 days after completion of treatment follow up was done by every fortnight for 1 month in both groups. Patients were assessed for relief in sign and symptoms adopting gradation method. Follow up period was one month after completion of the treatment to see any complication, recurrence and condition of the patients. All the cases were screened for essential haematology, bio-chemical and radiological investigations prior their enrolment for the study. The effect of the treatment was assessed on the basis of relief in Pain, stiffness, giddiness, tingling and numbness, loss of sensation and NDI Score where subjective criteria were assessed by VAS scale and gradation. Ranges of movements (ROM), were considered as the objective parameters. The ROM namely cervical flexion, cervical extension, left and right lateral flexion, rotation towards left and right were recorded according to the actual values of goniometric readings. The observed results in the study were subjected to statistical calculation to derive final conclusion.

Discussion on study was made on demographic observations and clinical findings. Conclusion of clinical study suggest that both the groups treatment protocol have shown highly significant difference was observed in Grivasandhishula (pain), Grivasandhistambha (Stiffness), NDI score and ROM (Range of Motion). There was increase in ROM as well as relief in pain, decreased stiffness as a result of increase ROM from before treatment to after treatment as a result of Marma Chikitsa and Physiotherapy. Because of that neck disability was reduced compare to before and result of NDI score was improved. Non-significant difference was observed in comparative effect of therapy in all laboratory investigation. Thus, it declares that the alternative hypothesis is accepted and the null hypothesis is rejected. i.e., Marma Chikitsa is more effective than conventional physiotherapy in the management of Grivasandhigata Vata w.s.r. Cervical Spondylosis.

 

 


 
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