| CTRI Number |
CTRI/2024/07/069921 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic management of low back with granules |
|
Scientific Title of Study
|
Clinical study to evaluate the add on effectiveness of Chandrashura granules as food supplement in the management of low back pain |
| 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 Rachana Yadavaraya |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manunatheshwara College of Ayurveada and Hospital Hassan |
| Address |
Department of Swasthavritta Evam Yoga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital ,B M road, Thanniruhalla,Hassan-573201, Karnataka, India
Hassan
KARNATAKA
573201
India |
| Phone |
8088824622 |
| Fax |
|
| Email |
rachanayadavaraya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gurubasavaraj Yalagachin |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manunatheshwara College of Ayurveada and Hospital Hassan |
| Address |
Department of Swasthavritta Evam Yoga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital ,B M road, Thanniruhalla,Hassan-573201, Karnataka, India
Hassan
KARNATAKA
573201
India |
| Phone |
9964620229 |
| Fax |
|
| Email |
drgurubasavarajy@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gurubasavaraj Yalagachin |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manunatheshwara College of Ayurveada and Hospital Hassan |
| Address |
Department of Swasthavritta Evam Yoga, Sri Dharmasthala Manjunathesgwara College of Ayurveda and Hospital,B M road, Thanniruhalla,Hassan-573201, Karnataka, India
Hassan
KARNATAKA
573201
India |
| Phone |
9964620229 |
| Fax |
|
| Email |
drgurubasavarajy@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Munjunathesheswara College ofAyurveda and Hospital,BM Road,THanniruhalla,Hassan-573201,Karnataka,India |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Munjunathesheswara College ofAyurveda and Hospital |
| Address |
Sri Dharmasthala Munjunathesheswara College ofAyurveda and Hospital,BM Road,THanniruhalla,Hassan-573201,Karnataka,India |
| Type of Sponsor |
Private 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 Rachana Yadavaraya |
Sri Dharmasthala Munjunathesheswara College ofAyurveda and Hospital Hassan |
Department of Swasthavritta evam Yoga,OPD number 9, Sri Dharmasthala Munjunathesheswara College ofAyurveda and Hospital,BM Road,THanniruhalla,Hassan-573201,Karnataka,India
Hassan
KARNATAKA |
8088824622
rachanayadavaraya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M545||Low back pain. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trayodashanga guggulu, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 450(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: along with it 12 grams of Chandrashura granules will be given,Pragbhakta,30 days with milk | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trayodashanga guggulu, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 450(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects fulfilling at least one of the
diagnostic criteria
2.Gender: All
3.Ready to sign informed consent
|
|
| ExclusionCriteria |
| Details |
1.History of spinal surgeries.
2.History of spinal injuries
3.Pregnant women
4.Lactating women
5.Known case of kidney stone
6.Known case of pelvic inflammatory disease
7.Known case of malignant disease
8.Known case of spinal tuberculosis
9.Known case of Diabetes mellitus
10.Known case of cauda equina syndrome
11.Those who are undergoing panchakarma procedures
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Straight leg raising test positive
2.Femoral nerve stretch test positive
3.Coin test positive
4.Schober’s test positive
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Visual Analogue Scale
2) Oswestry Disability Index
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
13/07/2024 |
| 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
|
Low back pain has the highest
prevalence among musculoskeletal conditions and is the leading cause of
disability. Globally, low back pain affects more than 540 million people. In
India, nearly 60% of the population has suffered from low back pain at some
point of time in their lifespan. Along with Conservative treatment dietary
supplements should be advised. Ayurveda termed Ahara
as Mahabhaishajya. In this study Chandrashura is selected as it is having
Vata-kaphahara and Balapushtivardhana properties and was
used in traditional medicine as pain reliever.
Keeping time constraint and palatability in mind an attempt is made to
transform Chandrashura beeja into
granular form which is ready to use as well as tasty. A minimum of 48
subjects reporting to SDM Hassan who are diagnosed with low back pain and
fulfilling inclusion criteria will be recruited and will be alternatively allocated into two
groups. control group : A minimum of 24 subjects will
be administered with Trayodashangaguggulu 2-2-2 (b/f)
for 30 days with lukewarm water and will be observed for changes. Data
will be collected before and after the study. study group : A minimum of 24
subjects will be administered with Trayodashangaguggulu DS 2-2-2 (b/f) for 30 days with lukewarm water + Chandrashura granules
12gm-0-12gm with
milk (b/f) and will be observed for changes . Data
will be collected before and after the
study |