| CTRI Number |
CTRI/2025/07/089915 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Prabhav of Rasnadi guggul and Raktamokshana in the managment of katigata shool |
|
Scientific Title of Study
|
A Clinical Efficacy of Rasnadi Guggul and Raktamokshana in the Management of Katigata Vata with special reference to Lumbar Spondylosis - A Randomized, Controlled, Clinical Trial |
| 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 Shrasy Chauhan |
| Designation |
P G Scholar |
| Affiliation |
S. G. M. P. G. Ayurvedic College and Hospital |
| Address |
Department of Shalya Ground Floor Saheri Ghazipur
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
9927801231 |
| Fax |
|
| Email |
sshrasy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Yadav |
| Designation |
Associate Professor |
| Affiliation |
S G M P G Ayurvedic College and Hospital |
| Address |
Department of Shalya Tantra Ground Floor Saheri Ghazipur
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
8310956315 |
| Fax |
|
| Email |
Rajeshyadav1211@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Yadav |
| Designation |
Associate Professor |
| Affiliation |
S G M P G Ayurvedic College and Hospital |
| Address |
Department of Shalya Tantra Ground Floor Saheri Ghazipur
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
8310956315 |
| Fax |
|
| Email |
Rajeshyadav1211@gmail.com |
|
|
Source of Monetary or Material Support
|
| S G M P G Ayurvedic College and Hospital Saheri Ghazipur Uttar Pradesh 233302 |
|
|
Primary Sponsor
|
| Name |
Dr Shrasy Chauhan |
| Address |
Department of Shalya Ground Floor Saheri Ghazipur Uttar Pradesh 233302 |
| 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 Shrasy Chauhan |
S. G. M. P. G. Ayurvedic College and Hospital |
O P D and I P D of Shalya Tantra Department
Ground Floor Saheri Ghazipur
Ghazipur
UTTAR PRADESH |
9927801231
sshrasy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC S.G.M.P.G. Ayurvedic College Saheri Ghazipur Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G318||Other specified degenerative diseases of nervous system. Ayurveda Condition: KATIKATARUNA-MARMAVIDDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasnadi Guggul, Reference: Brihat Nighantu Ratnakar Vatvyadhi, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Procedure | - | raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रक्तमोक्षणम्/ शोणितस्रावः/ अस्रविस्रुतिः/शस्त्रविस्रावणम् | (Procedure Reference: Sushrut Samhita, Procedure details: Two sittings in 15 days interval)
(1) Medicine Name: Placebo drug, Reference: 00roasted suji powder capsules, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Duration: 4 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from Katigata Vata (Lumber spondylosis).
Patients between age group 40-70 years of either sex.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The improvement will be assessed on the basis of relief found in the cardinal features of the disease. To assess the effect of therapy all the sign and symptoms will assigned score
depending upon their severity
Subjective Criteria:
Kati Shoola (pain in lumbar area)/ VA scale
Kati Stambha (stiffness of lumbar joint)
Kati Suptata (numbness)
Akunchan Prasarane Pravrutti Savedana (restricted movement)
Objective Criteria:
|
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
After completion of the treatment, patients were advised to visit after every 07 days for
follow up for at least one month.
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="30"
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)
|
20/07/2025 |
| 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 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
|
The whole research work will be summarized and
conclusion will be made on the basis of the observation which will be done on
the subjective and objective parameters. Result will be analyzed statically
& discussed accordingly |