| CTRI Number |
CTRI/2023/07/055641 [Registered on: 25/07/2023] Trial Registered Prospectively |
| Last Modified On: |
23/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [MARMA THERAPY & KATI BASTI] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE STUDY OF MARMA THERAPY ON KATIKATARUNA MARMA
AND KATI BASTI IN LUMBAR SPONDYLOSIS
|
|
Scientific Title of Study
|
COMPARATIVE STUDY OF MARMA THERAPY ON KATIKATARUNA MARMA
AND KATI BASTI IN DHATUKSHAYJANYA KATI SANDHIGATA VATA
(LUMBAR SPONDYLOSIS)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| priyankasihmar |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka |
| Designation |
PG Scholar Rachana Sharir |
| Affiliation |
Shri Krishna Govt Ayurvedic College & Hospital Kurukshetra |
| Address |
PG Department Rachana Sharir
Shri Krishna Govt Ayurvedic College & Hospital
Kurukshetra 136118
Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9671041141 |
| Fax |
|
| Email |
psingh7604@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka |
| Designation |
PG Scholar Rachana Sharir |
| Affiliation |
Shri Krishna Govt Ayurvedic College & Hospital Kurukshetra |
| Address |
PG Department Rachana Sharir
Shri Krishna Govt Ayurvedic College & Hospital
Kurukshetra 136118
Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9671041141 |
| Fax |
|
| Email |
psingh7604@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Sharma |
| Designation |
Associate Professor |
| Affiliation |
Shri Krishna Govt Ayurvedic College & Hospital Kurukshetra |
| Address |
PG Department Rachana Sharir
Shri Krishna Govt Ayurvedic College & Hospital
Kurukshetra 136118
Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
8295012823 |
| Fax |
|
| Email |
drs.sharma@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Govt Ayurvedic College & Hospital Kurukshetra 136118, Haryana |
|
|
Primary Sponsor
|
| Name |
PG Department Of Rachana Sharir |
| Address |
Shri Krishna Govt Ayurvedic College & Hospital Kurukshetra 136118, Haryana |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PRIYANKA |
PG Dept Of Rachana Sharir |
Room No. 18
PG Dept Rachana Sharir
Shri Krishna Govt Ayurvedic College & Hospital sec 8 Umri Road Kurukshetra 136118, Haryana
Kurukshetra
HARYANA |
9671041141
psingh7604@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shri Krishna AYUSH University ,Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M190||Primary osteoarthritis of other joints. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | marmacikitsA, मरà¥à¤®à¤šà¤¿à¤•à¤¿à¤¤à¥à¤¸à¤¾ | (Procedure Reference: Marma science and principles of marma therapy by Dr S K Joshi, Procedure details: Procedure details: Marma stimulation with a very simple method of giving pressure on marma points; the rate of applying pressure is in accordance with the heart beat and respiratory rate. This technique depends upon three basic things - 1. Identification of Marma point 2. Giving proper pressure on Marma point with the help of thumb and fingers 3. Relaxation of Marma point)
Duration: 28 days)
| | 2 | Comparator Arm | Procedure | - | kaTibastiH, कटिबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Clinical panchkarma by Dr Polepally Yadaiah, Procedure details: 1.In this, patients should be given oil massage to the back or lumbar region, buttocks, and legs.
2.After massage Nadi swedana should be given for 10-15 minutes.
3.Now make proper Masha pisthi by adding sufficient water to masha powder and prepare the
paste. Fix the ring with the help of prepared paste on the affected area.
4.Then pour lukewarm medicated oil into the ring for 20-30 minutes duration. The temperature
of the oil must be maintained constantly during the treatment period.)
(1) Medicine Name: Murchita Tila Taila, Reference: Bhaisajya ratnawali , Route: Topical, Dosage Form: Taila, Dose: 150(ml), Frequency: od, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from Kati Sandhigata Vata (Lumbar Spondylosis) from age of 30-70 years of either sex.
2. Patient with Katishoola, Katistambha, Kati Suptata, Akunchana Prasarana Pravrutti Savedana. |
|
| ExclusionCriteria |
| Details |
1.Patients below 30 years and above 70 years of age will be excluded.
2.TB of the spine
3.Auto-immune disorders associated with lumbar pain.
4.Uncontrolled diabetes mellitus, cardiovascular disease, neoplastic disorders.
5.Pregnancy.
6. Myelopathy.
7. Spondylisthesis, spina bifida, vertebral fractures, malignant disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses the efficacy of Marma therapy in Dhatukshayjanya sandhigata vata |
Duration of treatment: 28 days daily.
Follow up: 7th, 14th, 21st & 28th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses the efficacy of Kati basti in Dhatukshyayjanya sandhigata vata. |
Duration of treatment : 28 days daily.
Route of administration: local application on lumbar region.
Dose: 150ml
Follow up: 7th, 14th, 21st & 28th day. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/08/2023 |
| 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 Yet Recruiting |
| 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
|
Lumbar Spondylosis or Lumbar
osteoarthritis s is a degenerative disorder of the lumbosacral spine giving
rise to disc degeneration. It is characterized osteophyte formation leading to spinal
deformity, low back pain radiating down one or both lower extremities along with
joint space narrowing. The typical age of onset is 40-50 years irrespective of
sex.
Based on common clinical features
of lumbar osteoarthritis, it can be correlated to Dhatukshayjanya Kati
Sandhigat Vata. The cardinal features if this syndrome are Kati sandhi shula
(low back ache) , Kati stambha (stiffness) , Kati graha (restriction on
movements) , Prasaran akunchan vedana (pain at the knee joint during flexion
and extension) , Sparsha Asahyata (Tenderness). In ayurveda pain is cardinal
symptom of Vata dosha. Hence , in treating Dhatukshayjanya Kati sandhigata vata
(lumbar spondylosis), the primary concern should be the effective treatment of
vata dosha. Snehana is the best line of treatment in the management of
aggravated vata dosha.
Katikataruna marma is the marma
of the back region and is present on either side of the vertebral column, on
the earlike bones of the pelvis i.e sciatic notch.
Marma therapy is simply a non-pharmacological intervention
on the body to treat a wide range of conditions by applying pressure to
specific Marma points.
I here by evaluate the effiacay
of marma therapy and kati basti in Dhatukshayjanya Kati Sandhigat Vata |