CTRI Number |
CTRI/2024/03/063917 [Registered on: 11/03/2024] Trial Registered Prospectively |
Last Modified On: |
08/03/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Other (Specify) [PANCHAKARMA BASTI KARMA] |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To Evaluate Effectiveness of Erandamooladi Niruha Basti and Shampakadi Niruha Basti Karma in management of Gridrasi(Sciatica) |
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Effectiveness of Erandamooladi Niruha Basti and Shampakadi Niruha Basti in the Management of Gridrasi |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
CHANDU METRI |
Designation |
PhD Scholar |
Affiliation |
Government Ayurvedic Medical College BAngalore |
Address |
OPD 6
Ground floor
Department of Panchakarma
Government Ayurveda Medical college,Bangalore
Bangalore KARNATAKA 560009 India |
Phone |
9739317110 |
Fax |
|
Email |
akrmchandu@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Ananta Desai |
Designation |
Professor & HOD |
Affiliation |
Government Ayurvedic Medical College Bangalore |
Address |
OPD 6
Department of Panchakarma
Government Ayurveda Medical college
Bangalore
KARNATAKA
Bangalore KARNATAKA 560009 India |
Phone |
9448185896 |
Fax |
|
Email |
anantdesai30@gmail.com |
|
Details of Contact Person Public Query
|
Name |
CHANDU METRI |
Designation |
PhD Scholar |
Affiliation |
Government Ayurvedic Medical College BAngalore |
Address |
OPD 6
Ground Floor
Department of Panchakarma
Government Ayurveda Medical college
Bangalore
Bangalore KARNATAKA 560009 India |
Phone |
9739317110 |
Fax |
|
Email |
akrmchandu@gmail.com |
|
Source of Monetary or Material Support
|
GAMC Hospital Bangalore & Krishna Ayurveda College Sankeshwar |
|
Primary Sponsor
|
Name |
Chandu Metri |
Address |
department of Panchakarma,
Krishna AYurvedic Medical College |
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 Chandu Metri |
GOVERNMENT AYURVEDA MEDICAL COLLEGE BANGALORE |
OPD 6
Panchakarma Division
Department of Panchakarma
Government Ayurveda Medical college Bangalore,KARNATAKA Bangalore KARNATAKA |
9739317110
akrmchandu@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
GOVERNMENT AYURVEDA COLLEGE DHANWANTARI ROAD BANGALORE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M898||Other specified disorders of bone. Ayurveda Condition: GRUDHRASI, (2) ICD-10 Condition:M498||Spondylopathy in diseases classified elsewhere. Ayurveda Condition: GRUDHRASI, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | yoga-bastiH, योग-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: susruta samhita chiktsa sthana 38/43-45, Procedure details: Procedure
Purvakarma sambarasangraha of all the medicine & equipments and advised to pateient regrading basti
pradhana karma
bastipratidana
basti pratyagamana
lakshana of yoga ayoga and atiyoga
paschaatkarma ) (1) Medicine Name: Sampakadi niruha basti, Reference: Susruta samhita chiktsa sthana, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 8 Days | 2 | Comparator Arm | Procedure | - | yoga-bastiH, योग-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charaka samhita siddhisthana , Procedure details: Procedure
Purvakarma sambarasangraha of all the medicine & equipments and advised to pateient regrading basti
pradhana karma
bastipratidana
basti pratyagamana
lakshana of yoga ayoga and atiyoga
paschaatkarma ) (1) Medicine Name: Erandamooladi niruha basti, Reference: Charaka samhita , Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 8 Days |
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Subjects yogya for Basti karma,Subjects Presenting with classical signs and symptoms of Gridrasi,Sign like Sakthi nikshepa nigraha (SLR, i.e., straight leg rising test positive),Subjects of age group between 20 and 70 years either sex.
|
|
ExclusionCriteria |
Details |
1.Ayogya for Niruha Basti.
2.Uncontrolled diabetes mellitus, hypertension, tuberculosis of spine and hip joint, malignancy of spine or other organs
3.Fracture related to spine
4.Anemia (hemoglobin % <07.00 mg/dl)
5.Pregnancy.
6.Patients who have completed participation in any other clinical trial during the past six (06) months
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Pain,Radiating pain from lumbar to lower linmbs,difficulty in walking |
1st day ,8th day and 24th day |
|
Secondary Outcome
|
Outcome |
TimePoints |
Pratyatmalaksana of gá¹›idhrasi
CRP |
Baseline & 24th day |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
18/03/2024 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
18/03/2024 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" 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
|
The disease Gridhrasi is commonly seen in the society as a prominent problem. Gridhrasi listed among the Nanatmaja vatavyadhi is characterized by Stambha, Ruka, Toda and Spandana, initially affect Sphika (buttock) as well as posterior aspect of kati (waist) and then gradually radiates to posterior aspect of uru (thigh), janu (knee), Jangha (calf) and Pada (foot) Acharya Susruta has also mentioned Sakthishepana Nigrahanti (restricted movement of lower limb) as one additional symptom of Gridhrasi. In Vata-Kaphaj Gridhrasi; Tandra (drowsiness), Gaurav (heaviness) and Aruchi (anorexia) may also be present. This condition causes great discomfort to the patient and affects his daily routine as it is directly related to the locomotors system. Improper seating posture, irregular food habits, lack of proper sleep, travelling in jerky vehicles etc. are responsible for Sciatica. On the basis of symptoms of Gridhrasi; it can be equated with the disease sciatica in modern science. It occurs due to spinal nerve irritation and is characterized by pain in distribution of sciatic nerve. Low back pain and radiating pain due to lumbar disc prolapse are the major cause of morbidity throughout the world. Lifetime incidence of low back pain is 50-70% with incidence of sciatica more than 40%. However sciatica due to lumbar disc prolapse occurs only in 4-6% of the population. Despite the staggering annual costs of back pain to society there is paucity of well controlled clinical trials in the area of low back pain. | In today’s era quick pain relief is of prime importance to resume normal activities. Basti is considered as prime line of treatment in the Vataja disorders and deferent shodhana basti is mentioned in the classics for Vataja and Vata-kaphaja disorders. Keeping this as background, present comparative integrated study is proposed to see the effectiveness of Erandamooladi Niruha Basti and Shampakadi Niruha Basti in the management of Gridrasi†|