| CTRI Number |
CTRI/2025/05/086448 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the effect of guduchi siddhaksheer ghrut in management of lumbar spondylosis when administered through rectal route. |
|
Scientific Title of Study
|
A single-arm open-labelled clinical study to evaluate the efficacy of guduchi siddhaksheer ghrut basti in katisandhigata vata w.s.r. to lumbar spondylosis. |
| 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 Pratiksha Jaishankar Tripathi |
| Designation |
Post Graduate resident |
| Affiliation |
APMs Ayurved Mahavidyalaya, Sion |
| Address |
Department of Panchakarma, Second floor, APMs Ayurved mahavidyalaya, near sion railway staion, sion, mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8355803632 |
| Fax |
|
| Email |
drpratiksha.tripathi99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwajeet Jayavant Patade |
| Designation |
Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya, Sion |
| Address |
Department of Panchakarma, Second floor, APMs Ayurved mahavidyalaya, near sion railway staion, sion, mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9869055701 |
| Fax |
|
| Email |
drvishup@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishwajeet Jayavant Patade |
| Designation |
Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya, Sion |
| Address |
Department of Panchakarma, Second floor, APMs Ayurved mahavidyalaya, near sion railway staion, sion, mumbai
MAHARASHTRA
400022
India |
| Phone |
9869055701 |
| Fax |
|
| Email |
drvishup@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth R.V ayurved Hospital |
|
|
Primary Sponsor
|
| Name |
Dr. Pratiksha Jaishankar Tripathi |
| Address |
Department of Panchakarma, second floor, APMs ayurved mahavidyalaya, near sion railway staion, sion, mumbai |
| 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 Pratiksha Jaishankar Tripathi |
APMs Ayurved mahavidyala and seth R.V ayurved hospital sion |
Panchkarma department , OPD no 1
Mumbai
MAHARASHTRA |
8355803632
drpratiksha.tripathi99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya, Sion |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M15-M19||Osteoarthritis. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchi siddha ksheerghrut basti, Reference: Ashtang hruday sutra sthaan, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 120(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical signs and symptoms of Katisandhigata Vata. (Niraam avastha)
a. Katishoola (pain in low back)
b. Katistambha (stiffness of lower back)
c. Akunchana Prasarana Pravrutti Savedana (painful joint movements)
Patients aged between 18 and 60 years and all genders.
Diagnosed with lumbar spondylosis based on clinical and radiological finding.
Willingness to participate and provide informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with acute lumbar spine injuries or fractures.
History of spinal surgery or severe spinal deformities.
Presence of systemic diseases such as diabetes, rheumatoid arthritis, CA, or any major autoimmune
disorder
Pregnant or lactating women.
Patients not willing to consent.
Patient not eligible for basti karma. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Katishoola |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Katistambha
Akunchana Prasarana Pravrutti Savedana
|
14 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 4 |
|
Date of First Enrollment (India)
|
17/05/2025 |
| 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="6"
Days="2" |
|
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
|
Nowadays humans are suffering from many lifestyle-related disorders due to the adaption of modern lifestyle. Katisandhigata vata is one of them. It is not only clinical but also social, economic & public health problems affecting the general population indiscriminately. It is not a life-threatening condition, but it causes great discomfort and restriction in social and other activities [3]. 25% of females are prone to Sandhigata Vata where whereas 16% of males are affected due to it. Conventional treatments, including pharmacological interventions and physical therapy, often provide limited relief and may be associated with side effects. Guduchi siddhaksheer ghrut basti, an ayurvedic therapeutic procedure involves the administration of medicated Ksheerbasti prepared with guduchi. This study aims to evaluate the effectiveness of guduchi siddhaksheer ghrut basti in managing symptoms of lumbar spondylosis, potentially offering a holistic and safer alternative to conventional treatment. |