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CTRI Number  CTRI/2024/12/078543 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 23/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Research Study to Compare the Effectiveness of a Traditional Ayurvedic Treatment (Marmachikitsa) in Relieving Lower Back Pain (Kati Graha)  
Scientific Title of Study   A Randomized comparative study to evaluate the augmentative effect of marma chikitsa in Lumbar spondylosis (Katigraha) 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amrish Chanana 
Designation  Assistant Professor 
Affiliation  Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh Southwest Newdelhi-110073 India 
Address  Institute block 3rd floor Room no323 Department of Rachana Shareer Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh Southwest Newdelhi-110073 India
Institute block 3rd floor Room no323 Department of Rachana Shareer Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh Southwest Newdelhi-110073 India
South West
DELHI
110073
India 
Phone  8383028675  
Fax    
Email  amrish.chanana@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aswathy K P 
Designation  PG Scholar 
Affiliation  Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh Southwest Newdelhi-110073 India 
Address  Institute block 3rd floor Tutorial room Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh Southwest Newdelhi-110073 India
Institute block 3rd floor Tutorial room Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh Southwest Newdelhi-110073 India
South West
DELHI
110073
India 
Phone  7559841443  
Fax    
Email  draswathikp154@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aswathy K P 
Designation  PG Scholar 
Affiliation  Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh Southwest Newdelhi-110073 India 
Address  Institute block 3rd floor Tutorial room Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh Southwest Newdelhi-110073 India
Institute block 3rd floor Tutorial room Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh Southwest Newdelhi-110073 India
South West
DELHI
110073
India 
Phone  7559841443  
Fax    
Email  draswathikp154@gmail.com  
 
Source of Monetary or Material Support  
Ch.Brahm Prakash Ayurved Charak Sansthan 
 
Primary Sponsor  
Name  Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh Southwest Newdelhi India 
Address  Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar Najafgarh Southwest Newdelhi-110073 India 
Type of Sponsor  Government medical college 
 
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 Aswathy K P  Ch. Brahm Prakash Ayurved Charak Sansthan   Hospital Block, Department of Rachana Sharir and Kayachikitsa Opd no -1 and 6
South West
DELHI 
7559841443

draswathikp154@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ch Brahm Prakash Ayurved Charak Sansthan IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M472||Other spondylosis with radiculopathy. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: CCRAS textbook of Marma chikitsa and S K Joshi Marma Science and Principles of Marma therapy, Procedure details: Marma manipulation on effected sites at 3 times per day for 14 days.)
(1) Medicine Name: Trayodasanga guggulu, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Duration: 14 Days
(2) Medicine Name: Rasnasaptaka kwata, Reference: Sharanghdra samhita, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Duration: 14 Days
2Comparator ArmDrugClassical(1) Medicine Name: Trayodasanga guggulu, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Rasnasaptaka kwata, Reference: Sharanghdra samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  1) Post- traumatic patients having a history of fractures and dislocation of the lumbar and
lower back region. 2) 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) 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
combined effect of Marma therapy with oral medicine for 14 days on LROM will be determined in the patient of Lumbar spondylosis  14 days 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   20/01/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
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.

वायु à¤•टयाश्रीता: शुद्ध à¤¸à¤¾à¤®à¥‹ à¤µà¤¾ à¤œà¤¨à¤¯à¥‡à¤¤à¥ à¤°à¥à¤œà¤®

कटिग्रह à¤¸ à¤µà¤¿à¤¨à¥à¤œà¥‡à¤¯ à¤ªà¤‚गु: सक्थि à¤¦à¥à¤µà¤¯à¤¾à¤¶à¥à¤°à¥€à¤¤à¤¾ (gada nigraha; vatarogadhikara  19/60)

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.

2. 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.

3. MARMA THERAPY IN KATISHOOLA [Lumbago]. A non-invasive healing therapy
A review article based on Marma therapy on Katishoola in International Ayurvedic medical
journal

4. COMPARATIVE CLINICAL STUDY ON EFFICACY OF MARMACHIKITSA AND
STIMULATION OF MARMA BY TENS 

5. 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.

6. 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 Marma Kalantara Pranahra Marma 

1/2 A

Ilium bone, Sacrum bone, Sacroiliac joint, Ant. And                 posterior, Sacroiliac ligaments. Sacral plexus of nerves, Psoas major and liac muscles.

2

KUKUNDARA

Sandhi Marma Vaikalyakara Marma

1/2 A

Ilium bone, Ischium bone[no joint structure] . Inferior gluteal artery and vein. Inferior pudendal artery and vein. Sciatic nerve . Gluteal maximus and Levator ani muscles.

3

JANU

Sandhi Marma Vaikalyakara

 3 A

Knee joint. Posterior cruciate ligament, Oblique  posterior ligament. Plantaris and Gastrocenemus muscles. Popliteal artery and vein. Femur tibia and Patella bones. Medial popliteal nerve.

4.

GULPHA

Sandi Marma Rujakara Marma 2A

Superficial Peroneal Nerve

 

Extensor retinaculum

 

Deep Peroneal nerve

Extensor digitorum longus

Extensor hallucis longus

Tibialis anterior artery

 

Anterior tibial artery

 

Peroneal retinaculum on lateral side of ankle.

 

Peroneus tertius muscle

 

5.

KSHIPRA

Snayu Marma Kalantara 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.
2) 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.
 
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