| CTRI Number |
CTRI/2024/07/071745 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to know the Efficacy of Jambeera Pinda sweda and Greeva basti with Panchasneha taila in Manya stambha(Cervical Spondylosis) |
|
Scientific Title of Study
|
A Comparative Clinical Study on the Efficacy of Panchasneha taila Greeva Basti and Jambeera Pinda Sweda in the Management of Manyastambha (Cervical Spondylosis) |
| 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 Sparsha K O |
| Designation |
2nd year PG Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital Bengaluru |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 13 and OPD 26 Anchepalya Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
7019387553 |
| Fax |
|
| Email |
drsparshako@sdmayurbangalore.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun B Jainer |
| Designation |
Associate Professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 13 Anchepalya Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
9900940333 |
| Fax |
|
| Email |
draruns@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun B Jainer |
| Designation |
Associate Professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 13 Anchepalya Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
9900940333 |
| Fax |
|
| Email |
draruns@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr Sparsha K O |
| Address |
Dept of Panchakarma Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital OPD 13 and OPD 26 Anchepalya Bengaluru Karnataka 560074 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Sparsha K O |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
OPD 13 and OPD 26 Department of Panchakarma Bengaluru
Bangalore
KARNATAKA |
7019387553
drsparshako@sdmayurbangalore.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | grIvAbastiH, गà¥à¤°à¥€à¤µà¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Astanga hrudaya 22nd chapter, Procedure details: Greevabasti with panchasneha taila for 7 days )
(1) Medicine Name: panchasneha , Reference: sahasrayoga, Route: Topical, Dosage Form: Taila, Dose: 300(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: caraka samhita sutra 14th chapter , Procedure details: Jambeera pinda sweda- Purva karma,
1.Patient is asked either to sit on a chair or lie on prone position depending on comfort of the Patient.
2.Snehana is done by applying lukewarm Panchasneha taila over the neck and shoulder area
Pradhana karma,
1.The temperature of the hot bolus is checked on dorsum of palm before applying to the patient, if bearable it is gently rubbed over the back of the neck and shoulders in circular manner.
2.The procedure is performed for 35 minutes till sweating occurs and the patient feels light as well as signs of Samyak swedana lakshanas.
)
(1) Medicine Name: Panchasneha , Reference: sahasrayoga , Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting signs and symptoms of Manya stambha (Cervical spondylosis).
2.Patient of any socio-economic status, either gender.
3.Patients above 30 years and below 60 years.
4.Patient presenting clinical symptoms with or without radiological changes.
5.Patients who are ready to sign informed consent form.
|
|
| ExclusionCriteria |
| Details |
1.Cervical, Spinal or Shoulder surgery or implanted instrumentation.
2.Patient who are having any structural deformities of spine and need surgical care.
3.Conditions related to spine other than Manya stambha (Cervical spondylosis) such as Cervical dystonia.
4.Patient suffering from any infectious disease, chronic diseases (such as Rheumatoid arthritis, systemic lupus erythematosus, Ankylosing spondylitis, gout, Potts’ spine) or any skin disease at the neck region.
5.Patient with Major systemic disorders that may interfere with the course of treatment.
6.Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Significant reduction in Manya shoola (neck pain) measured using V A S Scale.
2.Significant reduction in Manya stambha (neck stiffness) using Gradings.
|
0th day (before treatment) and 8th day (after treatment)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in Range of movements.
2.N D I (Neck disability Index) questionnaire, to assess quality of life before and after treatment.
|
0th day (before treatment) and 8th day (after treatment) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2024 |
| 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="6"
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
|
Due
to improper regimens like sitting,
sleeping postures, and consumption of food in day-to-day life, this irregular
life style gradually leads to early degenerative changes. Constant improper
usage of neck may lead to early degeneration followed by neck stiffness and
other ailments of the neck.
Manya stambha
is one such condition explained under Vataja nanatmaja vyadhi
(1) Manya means Gala parshwa shira,
which means back of the neck (2). Stambha means Nishchalikarana
means stiffness (3). Symptoms of Manya stambha are Stambha
(Stiffness), Shoola (Pain) over neck region, which can be corelated with
Cervical spondylosis in contemporary science.
Cervical
spondylosis is a degenerative condition of cervical spine where pain and
restricted movements of neck are the common symptoms. This disease is now
becoming serious problem to working individuals due to its progressive nature.
More
than 85% of people over the age of 60 years are affected. About 10 million
persons per year affected in India alone. Prevalence of Cervical spondylosis is
similar in both sexes, although degree of severities greater in males. It has
been estimated that 75% of persons over the age of 50 years have narrowing of
spinal canal or intervertebral foramina and 50% of these cases have symptomatic
spondylotic changes in cervical spine occur at solitary disc space level in
15-40% of patients and multiple level in 60-85% of patients. C4-C7 most
commonly affected (4).
In Panchakarma, treatment principles
for Vataja vyadhi provides significant results in managing musculoskeletal
disorders especially in the management of shoola by Snehana, Swedana,
Mrudu Samshodana.
Greevabasti
is the procedure in which both properties of Snehana and swedana
are incorporated. Greevabasti comes in direct contact with affected
region. Greevabasti being opposite to Vata Dosha guna
that is Snigdha and ushna in nature alleviates the disease. Swedana
removes kleda along with the sweat from the body resulting in the
reduction of Gourava and Stambha (5).
Jambeera Pindasweda
is a modified type of Sankara sweda, Jambeera being Ushna
virya, Amla rasa which leads to shamana of Vata
& Kapha. Ushna and Snigda guna of Swedana
subsided the symptoms of Manya sthamaba.
Panchasneha taila
indicated in vataja shoola and stambha as it contains Rasna, Saindava, Devadaru, Bala, Dashamoola, Eranda taila, Tila taila, Varahi taila, Narikelaja taila, Goghrita.
It is having Vatahara, Shulahara, and Stambhahara properties.
Hence
“a comparative clinical study on the efficacy of Panchasneha taila Greevabasti
and Jambeera Pindasweda in the
management of Manya stambha, cervical
spondylosis is taken. |