| CTRI Number |
CTRI/2023/01/049143 [Registered on: 23/01/2023] Trial Registered Prospectively |
| Last Modified On: |
21/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Panchprasrutik Basti in Katishula(Low Back Pain) |
|
Scientific Title of Study
|
A Clinical Study to evaluate the efficacy of Panchaprasrutik Basti in the management of Katishula (Low Back Pain) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhashanjali Singh |
| Designation |
PG Scholar |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
Depatment of Panchkarma OPD No. 9 Dr. D.Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharastra , India 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9624760721 |
| Fax |
|
| Email |
singh.bhashanjali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamata Nakade |
| Designation |
HOD & Professor |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
Depatment of Panchkarma OPD No. 9 Dr. D.Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharastra , India 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9850241887 |
| Fax |
|
| Email |
mamta.nakade@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhashanjali Singh |
| Designation |
PG Scholar |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
Depatment of Panchkarma OPD No. 9 Dr. D.Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharastra , India 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9624760721 |
| Fax |
|
| Email |
singh.bhashanjali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil College of Ayurved and Research Centre,Pimpri |
|
|
Primary Sponsor
|
| Name |
Dr Bhashanjali Singh |
| Address |
Sant Tukaram Nagar, Pimpri, Pune, Maharastra , India 411018 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mamata Nakade |
Dr. D.Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharastra , India 411018 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhashanjali Singh |
Dr D.Y.Patil college of Ayurveda and Research Centre, Pimpri |
Depatment of Panchkarma OPD No. 9 Dr. D.Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharastra , India 411018
Pune
MAHARASHTRA |
9624760721
singh.bhashanjali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. DYPCA & RC INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M489||Spondylopathy, unspecified. 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: शा.उ. शं. ५-१, Procedure details: Basti is the administration of the medicated decoction through anal route.)
(1) Medicine Name: Panchprasrutik, Reference: च. सि. अ.८/४, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having symptoms Katishula (Lower back pain), Katigraha (Restriction of movement) Sparsha Ashatva(Tenderness).
2.Age 18-70 years.
|
|
| ExclusionCriteria |
| Details |
1.K/c/o Aamvata (R.A), Vatrakta (Gout)
2.Garbhini (pregnant lady)
3.Low back pain results from spinal fractures, infections, neoplasm.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relieve in symptoms like Lumber pain, Restriction of movement, Tenderness |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access the improvement in the flexibility and tenderness |
7 days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
01/04/2023 |
| 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="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is the clinical study to evaluate the effect of Panchprasutik Basti in the managment of Katishula (Low Back Pain)
Study design is Single arm clinical study.
Total 35 Patients will be enrolled.
Assessment of patients on 1st and 7th day
Total duration of study will be 18 months. |