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 |
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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
|
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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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M452||Ankylosing spondylitis of cervicalregion. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAMÂ (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
|
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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.
|
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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.
|
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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.
|
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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
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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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