| CTRI Number |
CTRI/2024/09/073608 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of MAHAUSADHYADI KASHAYAM in low back pain. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to evaluate the effect of Mahausadhyadi Kashayam in the management of 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 Himakashi Sharma |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai |
| Address |
Room No. 17, Department of Kayachikitsa, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
8851642710 |
| Fax |
|
| Email |
sharmahema1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvendu Rout |
| Designation |
Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai |
| Address |
Room No. 17, Department of Kayachikitsa, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9444881980 |
| Fax |
|
| Email |
drsrout@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himakashi Sharma |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai |
| Address |
Room No. 17, Department of Kayachikitsa, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet,Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
8851642710 |
| Fax |
|
| Email |
sharmahema1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Tamil Nadu, India 600123 |
|
|
Primary Sponsor
|
| Name |
Dr Himakashi Sharma |
| Address |
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Tamil Nadu, India 600123 |
| 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 Himakashi Sharma |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Room No. 17, Department of Kayachikitsa, Chennai Bangalore Highway, Chennai, 600123
Thiruvallur
TAMIL NADU |
8851642710
sharmahema1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital, Dept. of Ayurveda of SCSVMV, Nazarathpet, Chennai- 600123 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M512||Other thoracic, thoracolumbar andlumbosacral intervertebral disc displacement. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasna Saptaka Kashayam, Reference: Sarngadhara Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahausadhyadi Kashayam, Reference: Bhavapraksha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with classical symptoms of Katigraha such as pain and stiffness in lower back region. |
|
| ExclusionCriteria |
| Details |
Patients less than 18 years and more than 70 years of age
Patient complaining of numbness or tingling sensation
Patients reporting with low back pain resulting from Neoplasm, Infection, Rheumatoid Arthritis, Gout and Pott spine
Patient associated with any other systemic disorder or any history of autoimmune diseases
Post surgical backpain
History of trauma or fracture of spine
Pain radiating from low back pain to lower limb
Pregnant and Lactating women |
|
|
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 |
| Reduction in signs and symptoms of Katigraha |
31 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
21/09/2024 |
| 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="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
|
Kati Graha (Low Back Pain) is a condition in which Vata Dosha alone or in association with
Ama gets seated in the Kati region causing vitiation resulting in severe pain in the region.
According to WHO, most people experience Low back pain atleast once in their life. In 2020,
prevalence of Low Back Pain (LBP) was estimated at 619 million people globally and its
prevalence is expected to increase to 843 million by 2050. Low back pain remains the leading
cause of YLDs (Years lived with disability) globally . In India (2020), at Point, at Annual and
at Lifetime Prevalence of LBP was found to be 48% (40-56%), 51% (45-58%) and 66% (56-
75%) respectively . Ganesan et al reported in a cross sectional study in 2017, LBP prevalence
as 42.4% per year and 22.8% per week in young Indian adults aged 18 to 35 years. 1355 Young
adults with requirement of prolonged sitting were included in this study . Parallel to this
Katigraha is the condition wherein Vata Dosha is vitiated and causes the vitiation of Kapha.
The drugs which are Vatakaphahara will help in the management of Katigraha. |