| CTRI Number |
CTRI/2024/09/073237 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [NIRUHA BASTI AND KWATHAPANA] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Erandmooladi Niruha Basti and Erand Taila with Dashmoola Kwatha in Lumbar Spondylosis |
|
Scientific Title of Study
|
A comparative study of Erandmooladi Niruha Basti and Erand Taila with Dashmoola Kwatha in tha management of Katishoola with special reference 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 Sapna Shrivastava |
| Designation |
M.D. Scholar |
| Affiliation |
Government P.G. Ayurveda College and Hospital Varanasi |
| Address |
Department of Panchakarma Government P.G. Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India
Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8435133282 |
| Fax |
|
| Email |
sapnashrvstv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Mishra |
| Designation |
Reader |
| Affiliation |
Government P.G. Ayurveda College and Hospital Varanasi |
| Address |
Department of Kayachikitsa and Panchakarma Government P.G. Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9026310346 |
| Fax |
|
| Email |
doctorjyotimisra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Mishra |
| Designation |
Reader |
| Affiliation |
Government P.G. Ayurveda College and Hospital Varanasi |
| Address |
Department of Kayachikitsa and Panchakarma Government P.G. Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9026310346 |
| Fax |
|
| Email |
doctorjyotimisra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government P.G. Ayurveda College and Hospital Varanasi UP 221002
India |
|
|
Primary Sponsor
|
| Name |
Government P.G. Ayurveda College and Hospital Varanasi |
| Address |
Department of Panchakarma Government P.G. Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sapna Shrivastava |
Government P.G. Ayurveda College and Hospital Varanasi |
OPD no. 8/11 and IPD of Kayachikitsa and Panchakarma Government P.G. Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
8435133282
sapnashrvstv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Government Ayurveda College and Hospital Varanasi U.P., Mahayogi Guru Gorakhnath AYUSH University, Gorakhpur, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M470||Anterior spinal and vertebral artery compression syndromes. Ayurveda Condition: VATAVYADHIH, |
|
|
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 Samhita Siddhisthana 3/41, Procedure details: The prepared decoction will be given through the anal route for 16 days.)
(1) Medicine Name: Erandmooladi Niruha Basti, Reference: Charak Samhita Siddhisthana 3/41, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 650(ml), Frequency: od, Duration: 16 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Erand Taila with Dashmoola Kwatha, Reference: Chakradatt Chikitsa 22/56, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 16 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex between 25 to 70 years of age.
2. Patients who have history of less than 1 year. 3. Patients who have the signs and symptoms of Katishoola and radiological early degenerative changes.
4. Patients who are willing to sign the consent for study participation.
5. Patients who are able and willing to complete the treatment schedule.
6. Patients who fit into the criteria for Bastikarma. |
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 25 years and above 70 years.
2. Patients who have Spinal Tumor, Tuberculosis of vertebral bodies, Malignant diseases of the pelvis.
3. Patients who recently had lumbar surgery or implanted instrumentation or prostheses.
4. Patients with chronic metabolic pathologies ie; Ankylosing Spondylosis, Rheumatoid Arthritis, Psoriatic Arthritis, Gouty Arthritis.
5. Patients having referred pain in the lower back such as in case of Renal Stones, Appendicitis, Pancreatitis, PID, Leucorrhea, Abdominal Aortic Aneurysm.
6. Pregnant and Lactating women.
7. Patients with any immunocompromised disease like AIDS, Tuberculosis etc.
8. Epilepsy or any other serious systemic illness.
9. Patients unwilling to participate in the trial.
10. Patients who do not fit into the criteria for Bastikarma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in pain, numbness and stiffness |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete relief in chief complaints of Lumbar Spondylosis |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| Date of Study Completion (India) |
02/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study is Randomized, Parallel group study trial comparing the efficacy of Erandmooladi Niruha Basti and Erand Taila with Dashmoola Kwatha in the management of Katishoola (Lumbar Spondylosis). Patients were selected randomly from OPD and IPD of Department of Kayachikitsa and Panchakarma, Government P.G. Ayurveda College and Hospital, Varanasi.
A total no. of 60 patients were studied under two groups having 30 patients in each group-
Group A: In this group, 30 patients were treated with Erandmooladi Niruha Basti for 16 days.
Group B: In this group, 30 patients were treated with Erand Taila with Dashmoola Kwatha for 16 days.
Two follow ups were taken with the gap of 7 days after the completion of treatment - First follow up was taken on 23rd day and Second follow up was taken on 30th day in each group. Result obtained after statistical analysis: Group A: In this group, out of 30, maximum 04 patients (13.33%) got good improvement, while 25 patients (83.33%) got moderate improvement and 01 patient (03.33%) got mild improvement in overall subjective and objective parameters.
Group B: In this group, out of 30, maximum 01 patient (03.33%) got good improvement while 22 patients (73.33%) got moderate improvement and 07 patients (23.33%) got mild improvement in overall subjective and objective parameters.
Conclusion: Statistically significant difference was observed in trial group (Group-A) as compared to control group (Group-B) in terms of Katishoola, Katisuptata, Katistambha, Akunchana Prasarana Akshamata, Range of motion, SLR, Kellgren Lawrence Scale, VAS, ODI |