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临床试验/CTRI/2024/12/078543
CTRI/2024/12/078543尚未招募3 期

A Randomized comparative study to evaluate the augmentative effect of marma chikitsa in Lumbar spondylosis (Katigraha)

Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh Southwest Newdelhi India1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年1月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
combined effect of Marma therapy with oral medicine for 14 days on LROM will be determined in the patient of Lumbar spondylosis

研究概览

简要总结

A RANDOMIZED COMPARATIVE STUDY TO EVALUATE THE AUGMENTATIVE

EFFECT OF MARMA CHIKITSA IN LUMBAR SPONDYLOSIS (KATIGRAHA)

Introduction

In recent years the applied aspect of Marma Chikitsa, is drawing attention and gaining popularity, as

these sites are being directly utilized by Ayurvedic physicians to obtain therapeutic goals by controlled

physical stimulus on them. CCRAS, Govt. of India, has published a book “Marma Chikitsa-Basic

Tenets in Ayurveda and therapeutic approach” edition 2020. Manipulation of Marma is non-surgical,

non- pharmacological technique and cost effective.

Katigraha is a Vataja vyadhi with Kapha-anubandha which produces symptoms like pain and

stiffness of Kati. In Samhitas scattered references of Katigraha, it is said that Kati is sthana of

Vata, and Pakwashayagata prakupita vata produces various symptoms, one among which is

Katigraha . Katigraha in aged people is mostly considered as Apatarpana janya vikara .

Katigraha is mentioned as separate disease in Gada nigraha, Vata rogadhikara. The sthamba

produced in the Kati will hamper the gati of Vayu resulting in Kha vaigunya and all these in total

result in pain and stiffness of lower back region. Saranghadra also mentioned it as one of the

Vataja nanatmaja vyadhi.

वायुकटयाश्रीता: शुद्धसामोवाजनयेत्रुजम

कटिग्रहस*विन्जेयपंगु: *सक्थिद्वयाश्रीता(gadanigraha;vatarogadhikara19/60*)*

The symptoms of Katigraha can be correlated with Lumbar spondylosis. Low back pain with

stiffness is the main cardinal symptom in Lumbar spondylosis. This cardinal symptom is

comparable with the ‘Graha’ condition mentioned in Ayurveda classics. The lumbosacral part of

the spine is comparable with the ‘Kati’ mentioned in Ayurvedic texts. Hence, Lumbar spondylosis

in contemporary medical science can be correlated with the Katigraha (one of the eighty

Nanatmaja Vata Vikar) mentioned in Charak Samhita.

Lumbar spondylosis is a degenerative disorder of the lumbar spine characterized clinically by an

insidious onset of pain and stiffness and radiologically by osteophyte formation.

Cause- Bad posture and chronic back strain are the most common cause

Pathology-Primarily, degeneration begins in the inter-vertebral joints. This is followed by a

reduction in the disc space and marginal osteophyte formation. Degenerative changes develop in

the posterior facet joints. Osteophytes around the inter-vertebral foramen may encroach upon the

nerve root canal and thus interfere with the functioning of the emerging nerve.

Clinical features: Symptoms begin as low backache, initially worst during activity, but later

present almost all the time. There may be a feeling of ’a catch’ while getting up from a sitting

position, which improves as one walks a few steps. Pain may radiate down the limb up to the calf

(sciatica) because of irritation of one of the nerve root. There may be complaints of transient

numbness and paresthesia in the dermatome of a nerve root, commonly on the lateral side of the

leg or foot (L4 -L5, S1 roots).

Lumbar Spondylosis occurs in 6-10% of general population.

LACUNAE IN EXISTING KNOWLEDGE

There is case study available but there is no RCT which suggest the efficacy of manipulation

of Marma in Lumbar spondylosis.

PREVIOUS STUDY DONE

  1. A CONCEPTUAL ANALYSIS OF MARMA CHIKITSA IN GRIDHRASI

This review article suggests that by the use of appropriate pressure over the Marma points,

these vital and powerful points can be stimulated leading to biochemical changes in brain as

well as in the body, resulting in suppression of the symptoms like pain, stiffness, numbness

etc.

  1. MARMA CHIKITSA AND AGNIKARMA IN KATIGRAHA – A CASE STUDY

The result of the case study shows that Marma chikitsa along with Shamana chikitsa has

improved the Oswestry low back disability score, VAS and tenderness assessment score in the

patients of Katigraha.

  1. MARMA THERAPY IN KATISHOOLA [Lumbago]. A non-invasive healing therapy

A review article based on Marma therapy on Katishoola in International Ayurvedic medical

journal

  1. COMPARATIVE CLINICAL STUDY ON EFFICACY OF MARMACHIKITSA AND

STIMULATION OF MARMA BY TENS

  1. MARMA CHIKITSA IN THE MANAGEMENT OF GRIDHRASI W.S.R. TO SCIATICA-

A case report

The result of the study showed that there is improvement in stambha, toda, ruja, Straight leg

raising test and Braggards test in Gridhrasi or Sciatica after the treatment.

  1. CONCEPT OF MARMA THERAPY IN MANAGEMENT OF PAIN

RESEARCH QUESTION

Is combined therapy of manipulation of prishta sakthigata Marma with oral medicine for 14

days is more effective than oral medicine alone in improving the symptoms of Lumbar

spondylosis [Katigraha]?

HYPOTHESIS

Null hypothesis: There is no difference in efficacy between combined therapy of manipulation

of Marma with oral medicine and oral medicine alone in the management of Lumbar

spondylosis (Katigraha).

Alternative hypothesis: The combined therapy of manipulation of Marma with oral medicine

is more effective than oral medicine alone in the management of Lumbar spondylosis

(Katigraha).

AIM and OBJECTIVES:

AIM

To determine the difference between the efficacy of combined therapy of manipulation of

Marma with oral medicine and oral medicine alone in the management of Lumbar spondylosis.

OBJECTIVES:

1] To determine the difference between the efficacy of combined therapy of manipulation of

Marma with oral medicine and oral medicine alone in the movements (flexion, extension, lateral

flexion, rotation) of the lumbar region.

2] To determine the difference between the efficacy of combined therapy of manipulation of

Marma with oral medicine and oral medicine alone in Oswestry low back disability index

score.

LITERATURE REVIEW

The science of Marma known as Marma Vaigunyam is a dynamic part, especially described in

Sushrut Samhita and other Ayurvedic classics. Acharya Sushrut has described 107 Marmas and

classified them into various types based on location, involved structure and effect of injury.

According to Acharya Sushrut Marma comprises of Jala, Vayu, Tej, Satva, Raja, Tama, and

jivatma.

Brihatrayi has explained about the Marma and their impact on body but noteworthy

description of Marma is found in Pratyek- Marmanirdesham shariram adhyay of

Sharirasthanam in Sushrut samhita.

Achaya Charak has mentioned 107 numbers of Marma but discussed only Trimarma namely

Hridya, Shir, and Basti.

Vagbhata also mentioned about 107 Marmas in the Sareera sthana 6 th chapter and classified

them into 6 according to Dhatubheda.

ANATOMICAL STRUCTURE OF MARMA AREAS

S.no

Marma

Type

Anatomical****Structure

|1.

NITAMBHA

Asthi MarmaKalantaraPranahraMarma

1/2A

Iliumbone,Sacrumbone,Sacroiliacjoint,Ant.Andposterior,Sacroiliacligaments.Sacralplexusofnerves,Psoasmajorandliacmuscles.

|2

KUKUNDARA

Sandhi MarmaVaikalyakaraMarma

1/2A

Iliumbone,Ischiumbone[nojointstructure] .Inferior gluteal artery and vein.Inferiorpudendalarteryandvein.Sciaticnerve.GlutealmaximusandLevatoranimuscles.

|3

JANU

Sandhi MarmaVaikalyakara

3 A

Kneejoint.Posteriorcruciateligament,Obliqueposteriorligament.PlantarisandGastrocenemusmuscles.Popliteal artery and vein.Femur tibia andPatellabones.Medial popliteal****nerve.

|4.

GULPHA

Sandi MarmaRujakara Marma2A

SuperficialPeronealNerve

Extensor****retinaculum

DeepPeronealnerve

Extensordigitorumlongus

Extensorhallucislongus

Tibialisanteriorartery

Anteriortibialartery

Peronealretinaculumonlateralsideofankle.

Peroneustertiusmuscle

|5.

KSHIPRA

SnayuMarmaKalantara Pranahara Marma

1/2 A

Combined Tendon of Adductor hallucis

and Flexor and hallucis brevis.

Transverse metatarsal ligament.

Bifurcation of the first dorsal metatarsal

artery of plantar arch.

Lateral dorsal artery.

Superficial stratum of digital slip of

plantar aponeurosis.

Bifurcation of the first common digital

nerve.

Plantar digital nerves of first cleft.

Bifurcation of the medial terminal

branch of deep peroneal nerve.

Lumbricals.

Study Centre- PG Dept. of Rachana Sharir and Kayachikitsa, OPD & IPD, Hospital of CBPACS

Sample size - 70 (35 in each group)

n=Z^2×p×(1-p)/d^2

Z=standard normal variable (1.96)

P=prevalence 10% (.1)

d=error=10%=.1

n=1.96^2 ×.1 ×.9 /.1^2 =35

Duration of study – 12 months

STUDY PLAN



Total 70 patients of Lumbar spondylosis will be registered in the study from the OPD/IPD

of hospital CBPACS after informed consent and will be divided into two

groups (group A&B) each having 35 patients.



Detailed history, signs and symptoms and examination of a range of motion of lumbar

region will be carried out of all the patients. All the patients of group A (OPD

patients) will be treated with oral medicine of Ayurveda, Trayodashanga guggulu 500 mg/2

tab BD (Bhaishajya ratnavali, vatavyadhyahikara 98-101) with Rasnasaptaka kwatha (oral)

50ml BD )(Sharngandhara Samhita ,kwathadi kalpana 86-87) and all the patients of group

B (IPD patients) will be treated with stimulation of following Marma (five in number) along

with oral medicines of group A.



Marma points to be taken - 1) Nitamba 2)Kukkundara 3)Janu 4)Gulpha 5)Kshipra 18

After general Examination, based on the book (Marma Chikitsa Basic Tenets in

Ayurveda and Therapeutic Approaches) all the Marma sites will be identified and

manipulated on an empty stomach or after three hours of meals, by applying gentle pressure

with the thumb and supported by hand, 18 times on each Marma site, in coherence with

breathing. Manipulation of Marma will be done three times a day for 14 days.

Drugs used- Rasnasaptaka kwata and Trayodashanga uggulu. All the drugs will be provided

from the Hospital pharmacy or any other GMP certified pharmacy.

Preparation of Rasnasaptaka kwath - The patient will prepare the decoction of the powder as

follows. One and a half tablespoons full of ingredients are added with 200ml of pure water and

boiled under medium flame and reduced upto one-fourth (50ml) and filter the decoction (kashaya).

Dosage of Medicine

Kwath - 50ml oral B.D twice a day, morning and evening half an hour before food for 2 weeks.

Trayodasanga guggulu- 500 mg/ 2 tablet twice a day with Kwath for 2 weeks

All seventy patients will be assessed on the following parameters before and after treatment.

ASSESSMENT OF PATIENTS BEFORE AND AFTER TREATMENT

Sl.No

Assessment****criteria

Before****treatment

After****treatment

Follow up

|   1st day

7th day

.

14th day

21st day

|1.

Lumbar (ROM)

      |2.

Back pain (VAS scale)

      |3.

Oswestry low back disability index

Follow up will be done on 21st day i.e. after completing 14 days of treatment.

INCLUSION CRITERIA

  1. Patients irrespective of sex, presenting with signs and symptoms of Lumbar Spondylosis.

  2. Patient having findings of Lumbar spondylosis in plain lumbar X-Ray ( AP and Lat.)

  3. Subjects of the age group 20 to 60 years will be registered in both groups.

  4. Patients fit for stimulation of Marma.

EXCLUSION CRITERIA

  1. Post- traumatic patients having a history of fractures and dislocation of the lumbar and

lower back region.

  1. Patients having Lumbar deformities, Postural defects and Uncontrolled Diabetes,

Hypertension, Malignancy and Hepatitis. Major systemic disorders, Neurodegenerative

conditions of the spine (e.g. TB, malignancy)

All the above collected data along with the Demographic data will be filled in the case report

proforma.

STATISTICAL DESIGN

To assess the intervention’s effectiveness, a comprehensible statistical analysis will be

conducted to compare outcomes between two groups. After completion of clinical trial in both

outpatient and inpatient settings, the collected data will be statistically analysed. Subjective

parameters will be expressed as frequencies and percentages, while objective measure will be

presented as means and standard deviations. Group comparisons will be made using an unpaired

t -test to ensure reliable and interpretable results.

EXPECTED OUTCOME OF STUDY

This study will give the evidence based applied aspect of Marma in Lumbar spondylosis. We

may come out withmore effective treatment for Lumbar spondylosis.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients irrespective of sex, presenting with signs and symptoms of Lumbar Spondylosis.
  • Patient having findings of Lumbar spondylosis in plain lumbar X-Ray ( AP and Lat.) 3) Subjects of the age group 20 to 60 years will be registered in both groups.
  • Patients fit for stimulation of Marma.

排除标准

  • Post- traumatic patients having a history of fractures and dislocation of the lumbar and lower back region.
  • Patients having Lumbar deformities, Postural defects and Uncontrolled Diabetes, Hypertension, Malignancy and Hepatitis.
  • Major systemic disorders, Neurodegenerative conditions of the spine (e.g. TB, malignancy).

结局指标

主要结局

combined effect of Marma therapy with oral medicine for 14 days on LROM will be determined in the patient of Lumbar spondylosis

时间窗: 14 days

次要结局

  • Combined effect of Marma therapy and oral medicines for 14 days on Oswestry low back disability index will be determined in the patient of lumbar spondylosis.(14 days)

研究者

发起方
Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh Southwest Newdelhi India
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Amrish Chanana

Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh Southwest Newdelhi-110073 India

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