| CTRI Number |
CTRI/2024/11/077430 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Management of Katigraha with special reference to Lumbar disc diseases with Panchkarma |
|
Scientific Title of Study
|
A Clinical study to evaluate the outcomes of
ASHTAPRASRUTIKA BASTI AND SWALPA RASONA PINDA in the management of KATIGRAHA with special reference to Lumbar disc diseases
LUMBAR DISC DISEASES |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rubal Bamal |
| Designation |
PG Scholar |
| Affiliation |
PT. KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE, BHOPAL |
| Address |
PG Department OF Panchkarma Room NO.111, PT. Khushilal Sharma government autonomous ayurveda college and institute Bhopal(M.P)
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
8816923737 |
| Fax |
|
| Email |
drrubal16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Shukla |
| Designation |
Professor and Head of Department |
| Affiliation |
PT. KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE, BHOPA |
| Address |
PT. Khushilal Sharma government autonomous ayurveda college and institute Bhopal(M.P)
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
9425373046 |
| Fax |
|
| Email |
umeshayurvedabhopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rubal Bamal |
| Designation |
PG Scholar |
| Affiliation |
PT. KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE, BHOPAL |
| Address |
PG Department OF Panchkarma Room NO.111, PT. Khushilal Sharma government autonomous ayurveda college and institute Bhopal(M.P)
Bhopal
MADHYA PRADESH
462007
India |
| Phone |
8816923737 |
| Fax |
|
| Email |
drrubal16@gmail.com |
|
|
Source of Monetary or Material Support
|
| PT. KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE BHOPAL (M.P) |
|
|
Primary Sponsor
|
| Name |
PT. KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE BHOPAL (M.P) |
| Address |
PG DEPARTMENT OF PANCHAKARMA PT. KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE BHOPAL (M.P) INDIA 462007 |
| Type of Sponsor |
Government funding agency |
|
|
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 Rubal Bamal |
PT. KHUSHILAL SHARMA GOVERNMENT (AUTONOMOUS) AYURVEDA COLLEGE AND INSTITUTE BHOPAL (MP) |
PG DEPARTMENT OF PANCHAKARMA PT. KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE BHOPAL (M.P) 462007
Bhopal
MADHYA PRADESH |
8816923737
drrubal16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 1 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M498||Spondylopathy in diseases classified elsewhere. Ayurveda Condition: PRUSHTHA-GRAHAHÂ (KEVALAVATA), (2) ICD-10 Condition:M498||Spondylopathy in diseases classified elsewhere. Ayurveda Condition: PRUSHTHA-GRAHAHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: charak siddhi sthana 8, Procedure details: 20 patients of this group will be treated with Ashtaprasurtika Basti as Yapana
basti for 9 days in its classical method that is through anal route in 640 ml dose and 1 sodhan basti through anal route in 576 ml dose and Swalpa Rasona Pinda in dose of 60
mg/kg/bodyweight once a day for 10 days .)
(1) Medicine Name: swalpa rason pinda, Reference: chakradatta vata vyadhi 31-34, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 4(g), Frequency: od, Duration: 10 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Enema | 20 PATIENTS TO BE GIVEN SOAP WATER ENEMA 640 ML FOR 10 DAYS ROUTE: ANAL REGION PLACEBO CAPSULES 350 MG OD FOR 10 DAYS |
|
|
|
Inclusion Criteria
|
| Age From |
31.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both the sex between 31 to 60 years of age.[12]
Patients fulfilling the diagnostic criteria.
Patients willing to sign the written consent for participation in the study.
Patients fit for Basti Karma. |
|
| ExclusionCriteria |
| Details |
Patients contraindicated for Basti Karma.
Patients having Spinal tumor, Tuberculosis, Malignant disease of the pelvis or spine,
fracture of spine, Congenital or Acquired skeletal deformity.
Any traumatic condition of spine leading to paralysis.
Recent lumbar surgery or implanted instrumentation or prosthesis.
Pregnant and lactating women.
Having Chronic pathologies ex. Ankylosing spondylosis, Rheumatoid arthritis,
Psoriatic arthritis, Gouty arthritis or any other systemic illness. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of the study we would be able to demonstrate the effect of
Ashtaprasrutika Basti and Swalpa Rasona Pinda in the management of katigraha
(Lumbar disc diseases). |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is further expected that this study would be able to provide conclusive inputs to assess the efficacy of the Ayurvedic management of Katigrah(lumbar disc diseases) |
2 weeks |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/03/2025 |
| 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="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
|
It is expected that at the end of the study we would be able to demonstrate the effect of Ashtaprasrutika Basti and Swalpa Rasona Pinda in the management of katigraha (Lumbar disc diseases).It is further expected that this study would be able to provide conclusive inputs to assess the efficacy of the Ayurvedic management of Katigrah(lumbar disc diseases).
|