| CTRI Number |
CTRI/2025/06/088770 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
05/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
MANAGEMENET OF GRUDRASI W.S.R. SCIATICA |
|
Scientific Title of Study
|
A CLINICAL STUDY ON THE EFFICACY OF PATHYADI GUGGULU (ORAL) AND MATRA VASTHI WITH GOKSHURADHYA TAILA IN THE MANAGEMENT OF GRIDHRASI W.S.R TO SCIATICA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AVULA NAGA SRAVANTHI |
| Designation |
PG STUDENT |
| Affiliation |
DRBRKRGOVERNMENT AYURVEDIC MEDICAL COLLEGE |
| Address |
DRBRKRGOVERNMENTAYURVEDIC MEDICAL COLLEGEERRAGADDAHYDERABAD TELANGANA-500038
DRBRKRGOVERNMENT AYURVEDIC MEDICAL COLLEGEERRAGADDA HYDERABADTELANGANA-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
7981934218 |
| Fax |
|
| Email |
avulasravanthireddy333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR A SWAROOPA |
| Designation |
PROFESSOR |
| Affiliation |
DRBRKRGOVERNMENT AYURVEDIC MEDICAL COLLEGE |
| Address |
DRBRKRGOVERNMENTAYURVEDIC MEDICAL COLLEGEERRAGADDA HYDERABADTELANGANA-500038
DRBRKRGOVERNMENTAYURVEDIC MEDICALCOLLEGEERRAGADDA HYDERABADTELANGANA-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9866275613 |
| Fax |
|
| Email |
swaroopa.kusuma95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AVULA NAGA SRAVANTHI |
| Designation |
PG STUDENT |
| Affiliation |
DRBRKRGOVERNMENT AYURVEDIC MEDICAL COLLEGE |
| Address |
DRBRKRGOVERNMENTAYURVEDICMEDICALCOLLEGE
ERRAGADDA
HYDERABAD
TELANGANA-500038
DRBRKRGOVERNMENTAYURVEDICMEDICAL COLLEGE
ERRAGADDA
HYDERABAD
TELANGANA-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
7981934218 |
| Fax |
|
| Email |
avulasravanthireddy333@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DRAVULA NAGA SRAVANTHI |
| Address |
DRBRKRGOVERNMENTAYURVEDICMEDICAL COLLEGE
ERRAGADDA
HYDERABAD-500038 |
| 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 AVULA NAGA SRAVANTHI |
DR.B.R.K.R.GOVERNMENT AYURVEDIC MEDICAL COLLEGE |
DEPARTMENT OF KAYACHIKITSA OPD1DIVISION-1
DRBRKR GOVERNMENT AYURVEDIC MEDICAL COLLEGE
ERRAGADDA
HYDERABAD
TELANGANA-500038
Hyderabad
TELANGANA |
7981934218
avulasravanthireddy333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Dr.B.R.K.R Ayurvedic College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G541||Lumbosacral plexus disorders. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathyadi guggulu, Reference: Bhava prakasha, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -(2) Medicine Name: Gokshuradhya taila, Reference: vangasena, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are willing to participate in the study & sign the consent form.
Subjects with classical symptoms of Gridhrasi explained in classical texts like
ruk, toda, sthambha, gaurava etc .
Subjects who are eligible for Vasthi. |
|
| ExclusionCriteria |
| Details |
1. Subjects of age group below 20 yrs and above 65 yrs.
2. Subjects with uncontrolled metabolic and other systemic disorders.
3. Subjects with Neoplastic changes and congenital abnormalities in lumbar spine.
4. Surgical interventions of spine.
5. Pregnant women and lactating mothers.
6. Subjects who are not eligible for vasthi.
7. Subjects suffering from disease like tuberculosis, leprosy, spinal cord injury,
fracture of spine etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in walking ability and moderate relief of pain |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="0"
Months="2"
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
|
A Single arm study involves in the treatment of Gridhrasi with the help of Pathyadi guggulu and Gokshuradhya taila. The pathyadi guggulu and gokshuradhya taila are having drugs which are Anti-inflammatory & Analgesic in action and helps in reducing the inflammation of the sciatic nerve. The combination of oral adminisration of Pathyadi guggulu and Matra vasthi with Gokshuradhya taila provides relief from sciatic pain and improves mobility and functional ability of the nerve thus providing overall improvement in the quality of life, which is the main aim of the study. |