跳至主要内容
临床试验/CTRI/2025/01/079693
CTRI/2025/01/079693尚未招募3 期

A comparative study to evaluate the augmentative effect of Marma Chikitsa in Knee osteoarthritis (Sandhigatavata)

CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年2月10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
80
试验地点
1
主要终点
combined effect of marma therapy and oral medicine on KROM will be determined in the patient of sandigata vata(osteoarthritis)

研究概览

简要总结

“A comparative study to evaluate the augmentative effect of Marma Chikitsa

**in Knee osteoarthritis (Sandhigatavata)”

 INTRODUCTION

Marma chikitsa is based on a deep understanding of the design and working of the human body which utilizes various points or areas of the body for preventive and therapeutic health benefits using the various manipulative techniques to complex procedures. Marma, by definition are the various seats or specific locations of Prana in the body[1]. Marma points are anatomical sites where muscles, vein, ligaments, bones and joints meet together

SANDHIGATA VATA

Sandhigata vata is a type of Vata vyadhi which commonly occurs in old age due to Vata vitiation and depletion of body tissues (Dhatus) which causes  Sandhishool (pain in joints), Sandhishopha (swelling in joints),  Prasaranjanya Vedana ( pain during flexion and extension of the joints),Vata purana driti sparsha (sounds resembling that made when we rub against a ball.In modern science, it is correleated with osteoarthritis.

OSTEOARTHRITIS

Osteoarthritis is a degenerative joint condition. It causes pain, swelling and stiffness, affecting a person’s ability to move freely. Osteoarthritis affects the entire joint, including the tissues around it. It is most common in the knees, hips, spine and hands. Many factors can contribute to developing osteoarthritis. Some include a history of joint injury or overuse, older age and being overweight. It affects women more than men. Exercise and healthy eating to build strong muscles and keep a healthy weight can reduce symptoms. Surgery to replace joint is used in severe cases to reduce pain and regain mobility. Once pain and loss of movement function become chronic, people with osteoarthritis often experience restrictions in participating in meaningful activities, decreased well-being, and psychological distress.

The world health organization (WHO) estimates that about 73% of people living with osteoarthritis are older than 55 years, and 60% are female. However, prevalence rate can vary significantly depending on factors such as age, gender, geographic location, and socioeconomic status.

   According to a Study published in Indian journal of orthopedics, the prevalence rate of knee osteoarthritis was found to be 28.7% in India

 LACUNAE IN EXISTING KNOWLEDGE

· There are many studies which are available on the concept of Knee osteoarthritis (Sandhigatavata) and its management, but there is no RCT study on Janu, Gulpha, Kshipra Marma manipulation effect in the management of Knee osteoarthritis (Sandhigatavata).

 RESEARCH QUESTION · Is combined therapy of manipulation of Janu, Gulpha, Kshipra Marma with oral medicine for 14 days is more effective than oral medicine alone in improving the symptoms of Knee osteoarthritis (Sandhigatavata)?

 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 Knee osteoarthritis (Sandhigatavata).

· Alternative hypothesis: The combined therapy of manipulation of  Marma with oral medicine is more effective than oral medicine alone in the management of Knee osteoarthritis

(Sandhigatavata).

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   Knee osteoarthritis ( Sandhigatavata ).

   OBJECTIVES:

· Primary objective- To determine the difference between the efficacy of combined therapy of manipulation of Marma with oral medicine and oral medicine alone in the flexion of knee joint.

· Secondary objective- To determine the difference between the efficacy of combined therapy of manipulation of Marma with oral medicine and oral medicine alone in WOMAC  osteoarthritis index.

REVIEW OF LITERATURE

Marmas are explained in all Samhitas (Charak, Sushrut, Vaghbhat). Acharya Sushrut has explained 107 Marmas. Acharya Dhalhan explain the importance of Marmas as“Maryantiitimarmani” that means any trauma to these points may lead to death or may result in disability. According to Acharya Vaghbhat those sites which are painful on application of pressure and which shows abnormal pulsation are known as Marmas. Marma points are anatomical sites where muscles, vein, ligaments, bones and joints meet together. The injury to these Marma points may cause serious consequences. Sushrut Samhita gives detailed description of Marmas like number of Marmas their location, structures involved.

मर्माणिनाममांससिरास्नाब्वस्थिसन्धिसन्निपाताः, तेषुस्वभावतएवविशेषेणप्राणस्तिष्ठन्ति; तस्मान्मर्मस्व***-भिहतास्तांस्तान्भावानापद्यन्ते।। Su.Sh.6/16।।***

According to Acharya Sushrut

Marmas  are  the  points  where  muscles, veins,  ligaments,  bones  and  joints  meets. These  are            the places where the Prana (life) resides naturally.

According to Ashtang hridya

Marmas are the sites where muscles, bones, ligaments, artery, veins and joints meet and Prana is located there.

Those sites which are painful on application of pressure and which shows abnormal   pulsation are known as Marmas.

 Literature view of Sandhigatavata

Sandhigata vata is a type of Vata vyadhi which commonly occurs in old age due to Vata vitiation and depletion of   body tissues (Dhatus). The disease was first described by Acharya Charaka by the name of ‘Sandhigata Anila’ in Vata Vyadhi, Sandhigatavata is accepted by Acharya Chakrapani as Gulpha vata or Sandhigata vata. Acharya  Sushruta has described the  diseases in  Vatavyadhi  chapter   under the  subheading of   Sandhigata vata .   In    Vriddhavastha, all  Dhatus  undergo Kshaya,  Thus, leading to Vataprakopa  and making   individual  prone to many diseases.

 à¤µà¤¾à¤¤à¤ªà¥‚र्णदृतिस्पर्शःशोथःसन्धिगतेऽनिले।प्रसारणाकुञ्चनयोःप्रवृत्तिश्चसवेदना॥Ch.Chi.28/37॥

Vata   purana   driti  sparsha  (sounds  resembling  that  made  when  we rub  against  a  ballon), swelling   in joints,  pain  during flexion and extension.

There is no   separate explanation of sandigatavata but it is   explained   under Vatavyadhi in every Samhita.

Anatomical structure of Marmaareas****:****(According to CCRAS Marmachikitsa book- Basic tenets in ayurveda and therapeutic approaches)

 S.NO

Marma

 Type of Marma

 Anatomical structure

|1

JANU

Sandhi Marma

Sakha Marma

3 Angulas

· Articular capsule

· The medial and lateral patellar retinaculum

·  Oblique Popliteal ligament

· Arcuate popliteal ligament

· Tibial collateral ligament

· Fibular collateral ligament

· Intra capsular ligaments- anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL)

·  Articular discs -medial meniscus and lateral meniscus

· Patellar ligament

·  Pre-patellar bursa, infra patellar bursa and supra patellar bursa

· Common peroneal and tibial nerve

· Popliteal artery

· Popliteal vein

   |2

                  KSHIPRA

Snayu marma

Sakha marma

Half Angula

 Â· 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

· Dorsal and plantar interosseous

muscle

  |3

GULPHA

Sandhi Marma

Sakha Marma

2 Angulas

· Superficial Peroneal Nerve

· Extensor retinaculum

· Deep Peroneal nerve

· Extensor digitorum longus

    PREVIOUS STUDY DONE

1. A case study of Marma Chikitsa on Janu sandhigatavata

This study shows that Marma Therapy showed encouraging results with regards to the management of symptoms associated with Janu Sandhigata Vata (Osteoarthritis of Knee), in short duration of time. Also, the present study illustrates the efficacy of the administered therapeutic intervention in the management of symptoms associated with Janu Sandhigata Vata, Significant improvement was observed in the subjective parameters (Sandhi Shoola, Sandhi Shotha, Sandhi Stabdhata, and Sandhi Atopa) and objective parameters (WOMAC Index, ROM, Walking Time) analyzed during and after the completion of the study.  Thus, stimulation of the Marmas can balance the Vyana Vayu and Vata Dosha, resulting in the corresponding healing effect in diseases like Janu Sandhigatavata.

 2. A clinical study on effect of Marma therapyon Sandhigatavataw.s.r osteoarthritis

This study shows   that   Marma therapy    provided  better  relief    in  the  disesase  Sandhigatavata(osteoarthritis).  Out  of  15  patients,  completely remission  in   the  symptom

(Sandhishool,  Sandhishopa,  Stabdhata,  Sparshaasahtwa , Akuchana, Sandhi sphutana, Prasaranjanyo Vedana) of  Sandhigatavata  was   observed in   12 patients, markedly improvement was observed in  2 patients, moderately improvement  present in 1 patient .

 Other review studies

· Singh Jagjeet; Sabharwal   Pooja.  Exploring the Scientific    Potential of   Marma Therapy as a Nonpharmacological Intervention in Pain Management.  AYUHOM 9(1): p 14-18, Jan–Jun 2022. | DOI: 10.4103/AYUHOM.AYUHOM_7_2

· Singh Jagjeet; Sabharwal Pooja. Relevance of   Marma Sharira in Contemporary Science: A  Scientific Review. Journal 2): p 145- 149, Apr–Jun    2023.DOI: 10.4103/joa.joa_63_21

MATERIALS AND METHODS OF STUDY**-** 1. Study design – A Randomized Comparative Study.

2. Study Centre-   PG Dept. of Rachana Sharir and Kayachikitsa, DMS, hospital will work as co- investigative department only.

3. Sample size – 80

n=z2x P x (1-P)/d2

z= standard normal variable=1.96

p= prevalence = 30%

d= error = 10%

n = (1.96)2x0.3x0.7/0.12

n=80.67, n~81

     Duration of study – 12 months

4. Study plan

 Â· Total 80 patients of Knee osteoarthritis (Sandhigatavata) will be registered in the study from the OPD/IPD of hospital CBPACS after informed consent (Annexure-1 and 2) and will be divided in two groups (group A&B) each having 40 patients.

· Detailed history, signs and symptoms and examination by digital goniometer to check the  Knee region i.e. knee Flexion will be carried out of all the patients .All the patients of group A(comparator group) will be treated with oral medicine of Ayurveda (Yograj guggulu 500 mg/2 tab BD (Yogratnakar purva khanda vata vyadhi nidan shloka 8)  with Maharasnadi kwath 50ml BD oral (शा० à¤¸à¤‚० à¤®à¥¦ à¤–ं० 2/93) and all the patients of group B( case group) will be treated with manipulation of following  three Marma (as described in the book of CCRAS-Marmachikitsa) along with oral medicines of group A.

· Manipulation of Marma will be carried out after taking proper training from the workshops of Marma therapy.

· Marma points to be taken - 1*. Janu* 2. Gulpha 3. Kshipra

· After general Examination, all the Marma sites will be identified and Stimulated(as described in the book of CCRAS-Marmachikita)  empty stomach or after three hours of meals, by applying gentle pressure with 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. The Effect of it will be reviewed weekly.

· Follow-up will be taken after 7 days of complete treatment.

· Drugs used – Maharasnadi kwath and Yograj guggulu. All the drugs will be provided by the hospital pharmacy of CBPACS or any other GMP certified pharmacy.

· Preparation of Maharasnadi kwath - The powder of the kwath will be provided from the hospital pharmacy of CBPACS and any other GMP certified pharmacy. The patient will prepare the decoction of the powder as follows 1 and half tablespoon full of ingredients added with 200ml of pure water and boiled under the medium flame and reduced up to one fourth (50ml) and filter the decoction (kashya).

 Dosage of Medicine

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

Yograj guggulu- 500 mg/ 2 tablets twice a day with Maharasnadi kwath for 2 weeks.

Table 1: Assessment of patients before treatment and after treatment

S.No

Assessment     criteria

Before

treatment

                  After treatment

Follow-up

|   1st day

7th day

14th day

21th day

|1

WOMAC (pain index)[25]

      |2.

WOMAC (stiffness index)

      |3.

WOMAC (physical finding index)

      |4.

Range of Motion

(Flexion of knee joint) (By goniometer)

The patients will be reviewed weekly for symptomatic changes.

INCLUSION CRITERIA â€“

· Patient irrespective of sex,  presenting  with  sign  and  symptoms  of    Knee  osteoarthritis

(Sandhigatavata).

· Subjects of age group 40 to 70 years will be registered in both the groups.  Patients fit for manipulation of Marma.

EXCLUSION CRITERIA â€“

· Post traumatic patients having history of fractures and dislocation of knee and hip region. · Patients having knee deformities, postural defects and uncontrolled diabetes, hypertension, malignancy and hepatitis, TB, Renal disease, Cardiac disease.

All the above data findings before and after treatment, along with demographic details will be recorded in case record Performa  and will be Statically analysed.

                                   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 Knee osteoarthritis (Sandhigatavata). We   may   come  out  with more  effective  treatment  for   Knee  osteoarthritis (Sandhigatavata )

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
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1 Patient irrespective of sex, presenting with sign and symptoms of Knee osteoarthritis (Sandhigatavata).
  • 2 Subjects of age group 40 to 70 years will be registered in both the groups.
  • Patients fit for manipulation of Marma.

排除标准

  • 1 Post traumatic patients having history of fractures and dislocation of knee and hip region.
  • 2 Patients having knee deformities, postural defects and uncontrolled diabetes, hypertension, malignancy and hepatitis, TB, Renal disease, Cardiac disease.

结局指标

主要结局

combined effect of marma therapy and oral medicine on KROM will be determined in the patient of sandigata vata(osteoarthritis)

时间窗: 14 days

次要结局

  • combined effect of marma therapy and oral medicine on WOMAC index will be determined in the patient of sandigata vata(osteoarthritis)(14 days)

研究者

发起方
CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN
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

研究点 (1)

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