| CTRI Number |
CTRI/2025/03/081852 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of enema therapy prepared in two different ways in low back pain radiating to lower limbs. |
|
Scientific Title of Study
|
Comparative clinical study on Erandamooladi Niruha Basti using Kashaya and Rasakriya in Vatakaphaja Gridhrasi. |
| 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 P V Chithra Ramakrishnan Yadhav |
| Designation |
PG Scholar |
| Affiliation |
SDM College of Ayurveda and Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Thanniruhalla
Hassan
Karnataka
India
Hassan
KARNATAKA
573201
India |
| Phone |
9961159122 |
| Fax |
|
| Email |
chithraramakrishnan98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashvini Kumar M |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Thanniruhalla
Hassan
Karnataka
India
Hassan
KARNATAKA
573201
India |
| Phone |
8217505755 |
| Fax |
|
| Email |
ashvinipanchakarma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashvini Kumar M |
| Designation |
Professor |
| Affiliation |
SDM College of Ayurveda and Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Thanniruhalla
Hassan
Karnataka
India
Hassan
KARNATAKA
573201
India |
| Phone |
8217505755 |
| Fax |
|
| Email |
ashvinipanchakarma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital
Thanniruhalla
Hassan
Karnataka 573201
India
|
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda and Hospital |
| Address |
Thanniruhalla, Hassan, Karnataka 573201 |
| 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 P V Chithra Ramakrishnan Yadhav |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
OPD and IPD under all the departments of Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,
Thanniruhalla, Hassan, Karnataka, India, 573201
Hassan
KARNATAKA |
9961159122
chithraramakrishnan98@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M544||Lumbago with sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka Samhita Siddhisthanam, Procedure details: Basti prepared with Erandamooladi Kashaya)
(1) Medicine Name: Erandamooladi Niruha Basti, Reference: Charaka Samhita Siddhisthanam, Route: Rectal, Dosage Form: Not Applicable, Dose: 675(ml), Frequency: od, Duration: 3 Days(2) Medicine Name: Sahacharadi Taila, Reference: Astanga Hridaya Chikitsa Sthana 29/66-68, Route: Rectal, Dosage Form: Not Applicable, Dose: 80(ml), Frequency: od, Duration: 5 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka Samhita Siddhisthanam, Procedure details: Basti prepared with Erandamooladi Rasakriya)
(1) Medicine Name: Erandamooladi Niruha Basti , Reference: Charaka Samhita Siddhisthanam, Route: Rectal, Dosage Form: Not Applicable, Dose: 675(ml), Frequency: od, Duration: 3 Days(2) Medicine Name: Sahacharadi Taila, Reference: Astanga Hridaya Chikitsa Sthana 29/66-68, Route: Rectal, Dosage Form: Not Applicable, Dose: 80(ml), Frequency: od, Duration: 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants fulfilling the diagnostic criteria
2. Age between 18-60 years irrespective of gender
3. Participants fit for Basti Karma.
4. Participants who are willing to participate and sign the informed consent form.
5. Participants with positive Straight Leg Raising (SLR) test.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women.
2. Uncontrolled Type 1 & 2 Diabetes mellitus & Hypertension.
3. Diagnosed cases of systemic disorders like heart disease, renal failure and liver disease which may interfere with the course of the treatment.
4. History of HIV, HBsAg, Carcinoma and Tuberculosis.
5. Fractures of pelvis and femur.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment will be based on Samyak Basti Lakshanas, Retention time of Basti Dravya, Number of Vegas. Assessment of Gridhrasi will be based on Ruk (pain)- Visual Analogue Scale (0-10), Stambha (stiffness)- Schober’s Test, Toda (pricking sensation), Aruchi(Anorexia), Gourava(Heaviness), Tandra(drowsiness), Straight Leg Raising Test. |
0th day, 5th day, 20th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvemnt in ease of life |
20days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
18/03/2025 |
| 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="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
|
Basti is the prime treatment modality among panchakarma
and it is referred as Ardha Chikitsa. Niruha Basti therapy is applied
for various ailments in which Kashaya being a crucial ingredient.
However, Kashaya must be freshly prepared and has a shorter shelf life. Therefore,
its essential to adapt the prepration process of Kashaya to extend its shelf
life without losing its medicinal value. In this context, Erandamooladi
Niruha basti which is widely used in clinical practice, has
been choosen and Rasakriya is prepared from Erandamooladi Kashaya
which offers the benefit of longer shelf life and storage compared to
traditional method of Kashaya prepration. Shelf life of Rasakriya
is 1 year as mentioned by sharangadhara samhitha and no preservatives
added, this Rasakriya is prepared once before the start of the study and
stored in air tight container, during the preparation of Kashaya,Rasakriya is added. Prepared Rasakriya
is mixed into warm water and stirred continuously for 2 minutes until it is
fully dissolved during the process of Basti prepration which saves the
time.
The
prevalence rate of sciatica varies significantly ranging from 1-6% in the
general population and from 40-70% in working population. It can cause significant economic burden due
to loss of work productivity so study for its effective management can reduce
its burden. So to fulfill the expectations from the ayurvedic field and to find
out effective and safe therapy for Gridhrasi and the duration required
for the prepration can be minimized,which may prove beneficial for ayurvedic
practices and Basti treatments.Therefore this particular study has been
choosen. |