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CTRI Number  CTRI/2022/10/046713 [Registered on: 21/10/2022] Trial Registered Prospectively
Last Modified On: 05/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To manage pain in cervical region with marma chikitsa and abhyanga-nadi sweda  
Scientific Title of Study   A comparative clinical study on the efficacy of marma chikitsa with sthanika abhyanga and nadi sweda in the management of manyastambha w.s.r to cervical spondylosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhopinder Singh 
Designation  Phd Scholar 
Affiliation  Parul Institute Of Ayurveda 
Address  Shalya Tantra Opd Number 106 And Ipd Parul Ayurveda Hospital Parul Institute Of Ayurveda Parul University Taluka Bawaghodia 391760 Gujrat Vadodara India

Vadodara
GUJARAT
391760
India 
Phone  7006333297  
Fax  02668260201  
Email  bhopinderthakur1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajiv Dole  
Designation  Professor 
Affiliation  Parul Institute Of Ayurveda 
Address  Room No 402 Department Of Shalya Tantra Parul Institute Of Ayurveda Parul University Taluka Bawaghodia 391760 Gujrat Vadodara India

Vadodara
GUJARAT
391760
India 
Phone  7006333297  
Fax  02668260201  
Email  ddrrajiv7@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajiv Dole  
Designation  Professor 
Affiliation  Parul Institute Of Ayurveda 
Address  Room No. 402 Department Of Shalya Tantra Parul Institute Of Ayurveda Parul University Taluka Bawaghodia 391760 Gujrat Vadodara India

Vadodara
GUJARAT
391760
India 
Phone  7006333297  
Fax  02668260201  
Email  ddrrajiv7@gmail.com  
 
Source of Monetary or Material Support  
Ayurved Hospital Parul Institute Of Ayurved Parul University Limbda Tal.Waghodia 391760 Distt Vadodara Gujarat 
 
Primary Sponsor  
Name  Parul Ayurved Hospital 
Address  Shalya Tantra Opd Number 106 And Ipd Parul Ayurved Hospital Parul Institute Of Ayurved Parul University Limbda Taluka Waghodia 391760 Vadodara 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 Bhopinder Singh  Parul Ayurved Hospital,Urmilla ayurvedic medical college and hospital   Room No. 402 Department Of Shalya Tantra Parul Institute Of Ayurveda Parul University Taluka Bawaghodia 391760 Gujarat Vadodara India
Vadodara
GUJARAT 
7006333297

bhopinderthakur1@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Parul institute of ayurveda (parul university)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: MANYASTAMBAH, (2) ICD-10 Condition:Z729||Problem related to lifestyle, unspecified. Ayurveda Condition: MANYASTAMBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsAमम.िचिक[ा (Procedure Reference: , Procedure details: 14 days/twice a day)
2Comparator ArmProcedure-nADIsvedaHनाडीeेदः (Procedure Reference: , Procedure details: 14 days /once a day )
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Aged between 20 to 60 years.
2 Patient fulfilling diagnostic criteria will be included in the study.
3 Having the classical signs and symptoms of cervival spondilosis stabdhata (stiffness),ruk (pain), toda (pinning sensation)
4 Patient fit for marma therapy 
 
ExclusionCriteria 
Details  1 Patients below the age of 18 and above the age of 60 were excluded.
2 Patients suffering from malignancy, major disorders of spine and major generalized diseases like C.C.F, IHD, Diabetes, renal disorders and immune compromised patients were excluded.
3 Patient who need other emergency intervention like surgery.
4 Patient suffering from cervical myelopathy and cervical radiculopathy will be excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of manipulation and stimulation of Marma points for fast relief pain and stiffness as in the
management of Manyastambha.  
15th day 
 
Secondary Outcome  
Outcome  TimePoints 
To standardise the procedure of manipulation and stimulation of Marma points as in the management of Manyastambha.   1 year 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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 3 
Date of First Enrollment (India)   10/11/2022 
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="6"
Days="2" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

A COMPARATIVE CLINICAL STUDY ON THE EFFICACY OF MARMA CHIKITSA WITH AGNIKARMA IN THE MANAGEMENT OF MANYASTAMBHA W.S.R TO CERVICAL SPONDYLOSIS

 

                                                                NEED OF STUDY

•       Manyastambha is a disease mentioned in Ayurvedic classical texts and is characterized by stiffness or rigidity of the neck, followed by pain where neck movements are impaired. It is considered as one among the nanatmaja vata vyadhis. About 10 million persons per year affected in India alone. Prevalence of Cervical Spondylosis is similar in both sexes although degree of severities greater in males. The prevalence of sciatica varies considerably ranging from 2% to 45% . C most 4-7 commonly affected.

•        In the present era, Manyastambha is a commonly occurring disease, which may be correlated to cervical spondylosis due to the similarity of their symptoms. The frequency of its occurrence can be attributed to change in lifestyle, stressful conditions, travelling, improper sitting and sleeping postures, excessive use of computers, irregular working orders and dietary habits. Cervical spondylosis is one such disease which adversely affects quality of life for its heavy disease burden and also affects economically for its high treatment costs. According to a study there is a great association between cervical spondylosis and migraine, those with cervical spondylosis commonly exhibit a higher risk of migraine than those without cervical spondylosis. This Cervicalgia affects work life where a person never want to waste his precious working day, also faces difficulty in performing routine activities in the later stages of the disease causing disturbed social life.

•       As per modern science, the treatment line for cervical spondylosis includes administration of anti-inflammatory, antibiotic drugs, conservative treatment such as stretching exercises, neck belt and repeated injections of botulinum toxins for temporary relief which may help to act on initial stages of this disease where there are inflammatory changes. When the disease progresses to the next stage, degenerative changes in bones of cervical region occurs and this can be effectively managed by snehana and swedana procedures and also with Marmachikitsa. In Ayurveda, snehana and swedana the is the commonest management of manyastambha.

•        In mamachikitsa there is a need to focus on manipulating and stimulating marma points in the management of diseases. As a treatment point of view, Marmachikitsa acts as an easy and quick solution to resolve such problems. A judicious application of pressure on appropriate marma can restore the normal functioning of prana (in diseased body parts).

•       Till now there are not much research work done on marma for therapeutic significance. So this topic needs to be explored for the benefit of Ayurveda faternity and mankind.

•       Hence, this study is planned to compare the effects of Marma therapy with Agnikarma in the management of manyastambha.

•       The major advantage of this study is that it is cost effective and non-invasive.

                                                              RESEARCH QUESTION

•       Whether the Marma chikitsa will prove to be more effective in comparison with that of Agnimarma adopted in Manyastambha?

                                                AIM-

•       To evaluate the comparison   of Marma chikitsa and agnikarma in Manyastambha w.s.r to Cervical spondylosis.

                                                                     OBJECTIVE

•       To study the effect of manipulation and stimulation of Marma points as in the management of Manyastambha.

•       To study the effect of Agnikarma in the management of Manyastambha.

      •   To compare the efficacy of Marma therapy with Agnikarma in the management of Manyastambha.

HYPOTHESIS-

H0

•       (Null Hypothesis)

       Nither Marma chikitsa nor  Ankara procedure is  effective  in the management of Manyastambha.

•       (Alternate hypothesis)

      H1 Marma chikitsa is more effective than agnikarma in management of  Manyastambha.

. • H2 Agnikarma is more effective than marma chiktsa  in  management of  Manyastambha.

• H3Marma chikitsa and Agnikarma   have similar effects in management of Manyastambha.

MATERIALS AND METHODS

 SOURCES OF DATA –

 1.Literary source – All classical, regional literature, modern literature and contemporary texts including the journals and internet sources about the disease, drug and procedures will be reviewed and documented for the study.

2.Clinical source – 144 cases of will be selected for the study from the IPD and OPD of Smt.Urmilla Devi Ayurvedic College of Medical Sciences and Hospital, Hoshiarpur.

 

METHODS OF COLLECTION OF DATA 1. Sample size – 144

Group A – Trial

Group B – Control

 2. Study design – Randomized controlled clinical trial

 

3. Duration of treatment – 14 days 

4. Follow up after – 14 days and 1 month

5. RESCUE MEDICINE: In case of condition suggestive of possible deterioration of health appropriate measure will be taken.

yogaraja Guggulu ,bruhatvata Chintamani rasa

INCLUSION CRITERIA

•      Aged between 20 to 60 years.

  • Patient fulfilling diagnostic criteria will be included in the study.
  • Patient irrespective of gender, religion,occupation ,socio-economic status etc.will be included in this study.

• Having the classical signs and symptoms of cervival spondilosis stabdhata (stiffness),ruk (pain), toda (pinning sensation)

  • Patient with controlled diabetes mellitus and other systemic diseases such as hyperthyrodism and hypothyrodism.
  • Patient fit for marma therapy
  • Both gender patients attending the OPD and IPD of will be included.

EXCLUSION CRITERIA:

•       Patients below the age of 18 and above the age of 60 were excluded.

•       Patients suffering from malignancy, major disorders of spine and major generalized diseases like C.C.F, IHD, Diabetes, renal disorders and immune compromised patients were excluded.

•       Patient who need other emergency intervention like surgery.

•       Patient suffering from cervical myelopathy and cervical radiculopathy will be excluded.

•       Pregnant, menstruating females and breast feeding mothers will be excluded.

•       Chronic cases of cervical spondylosis with history of more than 2 years.

•        Subjects with evidence of congenital anomalies of the spine, cervical fractures, trauma ,epidural abscess , Pott’s spine ,CA etc.

•       Refusal to provide consent for the study.

STANDARD OPERATING PROCEDURE FOR MARMA THREAPY

PURVA KARMA:

·       Check all the vitals of the patient.

·       Check the food taken is digested.

·       Keep at least 3 to 4 hours of gap after meals.

·       Cleaning of area to be operated with cotton, cloth or soft towel.

·       Noise free room with one helper technician specially in case of female patient, one female technician should be there as per protocol.

Pradhaan Karma:

  • Make the patient to sit in comfortable position.
  • Advise him/her to feel relax and take stable breaths.

•       Two types of marma methods are used – Marma manipulation and Stimulation.

 

MANIPULATION:

·       It is the mechanical force used to correct the pathology

·       There are different types of tractions used accordingly to the site and condition.

·       Manipulation done in required condition.

 

PROCEDURE:

  • Elicit the painful point
  • Give slight movements on the affected area with little pressure and support
  • Done only on first day of treatment.

 

STIMULATION: Pressing and releasing on vital spots for increasing local energy and pain reduction.

PROCEDURE:

•       Stimulation of marma points ( Amsa marma , krikatika marma ,urvi marma,Karpura marma ,manibanda and kaipra marma )one by one 12/16/18 times/point according to severity for mild, moderate, sever respectively with suitable intensity of pressure.

 

VARIOUS INTENSITY OF PRESSURE AND IT’S INDICATION:

•       ¼ matra pressure - Superficial pressure

Pressure intensity equal to that of touched with either side of the thumb.

•       ½ matra pressure    - Intensity equal to that of half the portion of soft pulp of the first interphalangeal joint of the middle finger

•       1 matra pressure     - Intensity equal to that of soft pulp of first interphalangeal joint of the middle finger / deep pressure.

•       Advice the patient to exhale on every stimulation with finger/thumb/palm (According to mathirai pressure) and inhale on releasing pressure.

·       After two rounds of initiation of Marma points, smear finger/palm with lukewarm medicated oil and gently apply over marma point.

·       Give 2 sittings to patient in a day for 14 days regularly.

PASCHAT KARMA:

·       Check all the vitals of the patient again.

·       Patients should take complete rest for at least 10 to 15 minutes.

·       Patient can take bath with lukewarm water after rest.

·       After treatment to each patient, it is necessary to touch the wall or any wooden object before treating the next patient, this is to avoid the transfer of the body heat from one patient to another. 

STANDARD OPERATING PROCEDURE  FOR  ABHYANGA  AND NADI SWEDA

Purva Karma:

• Moisten the skin surface before starting Abhyanga with towel dipped in lukewarm water.

• Check the food taken is digested or keep at least 3-4 hours of gap after meals.

• Check the vitals of the patient before Abhyanga.

• Easy garments to wear according to part exposed and oleation to be done.

Pradhaan Karma:

 1. Instruct the patient  to lie in prone posture on panchkarma table

2.  Sthanika abhyanga is administered (head ,neck ,shoulders region)to the patient.

3.After abhyanga give nadi sweda with dashamoola quatha to the patient.

 

 

 

 

Paschyat Karma:

 1.Patient should take complete rest for at least 15 minutes in comfortable position.

2. Check the vitals of the patient.

3. Patient can take bath in leukwarm water after rest.

ASSESSMENT CRITERIA

Assessment of the effect of treatment will be done with following parameters.

SUBJECTIVE CRITERIA:

Subjective parameters: parameters will be assessed on 1st, 7th and 14th day.

Manyashoola (pain) by VAS Analogue scale

 

 

GRADING (MANYASHOOLA)

ASSESSMENT

Grade 0

No pain

Grade 1

Mild, Pain occasionally (1-3 score)

Grade 2

More than mild but tolerable pain (4-6 scores)

Grade 3

Severe pain, continuous (7-10 score)

b)Stambha (Stiffness)

GRADING

ASSESSMENT

Grade 0

Absent

Grade 1

Mild, occasionally

Grade 2

Moderate, for 30-1 hr daily

Grade 3

Severe, persistent

 

 

 

 

 

 

 

  • GAURAVA (Heaviness)

GRADING

ASSESSMENT

Grade 0

Absent

Grade 1

Mild, occasionally for 10-30 mins

Grade 2

Moderate for 30-1 hr

Grade 3

Severe persistence>1 hr

 

•       CHIMCHIMAYAN (Numbness)

GRADING

ASSESSMENT

Grade 0

No chimchimayan

Grade 1

Mild, occasionally

Grade 2

Moderate, during work

Grade 3

Severe, continuous

 

•       OBJECTIVE PARAMETERS

CERVICAL MOVEMENT

NORMAL MOVEMENT IN DEGREE

1. Flexion

50

2.Extension

60

3.Left and Right flexion

45

4.Right and Left Rotation

80

 

•       MOBILITY FLEXION

GRADING

ASSESSMENT

Grade 0

Normal i.e., 50 degrees, able to touch chin & chest

Grade 1

38 to 49 degree of total neck movement

Grade 2

25 to 37 degree of total neck movement

Grade 3

13 to 24 degree of total neck movement

Grade 4

No flexion of neck

 

  • EXTENSION

GRADING

ASSESSMENT

Grade 0

Normal i.e., 60-degree extension of neck upto back

Grade 1

45 to 59 degree of total neck movement

Grade 2

30 to 44 degree of total neck movement

Grade 3

15 to 29 degree of total neck movement

Grade 4

No extension of neck

 

  • LATERAL FLEXION (RIGHT & LEFT)

GRADING

ASSESSMENT

Grade 0

Normal i.e., 45-degree ear touch to shoulder tip

Grade 1

34 to 44 degree of total neck movement

Grade 2

23 to 33 degree of total neck movement

Grade 3

12 to 22 degree of total neck movement

Grade 4

No flexion of neck

 

•       ROTATION OF THE NECK (RIGHT & LEFT)

GRADING

ASSESSMENT

Grade 0

Normal i.e., 80 degrees, able to make complete rotation

Grade 1

60 to 79 degree of total neck movement

Grade 2

40 to 59 degree of total neck movement

Grade 3

20 to 39 degree of total neck movement

Grade 4

No rotation of neck

 

 

 

 

 

  

 

 

 

 

 

 

 
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