| CTRI Number |
CTRI/2026/03/105484 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL STUDY TO EVALUATE EFFECT OF SHADANGA GUGGULU IN THE MANAGEMENT OF KATIGRAHA (LUMBAR SPONDYLOSIS) |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE THERAPEUTIC EFFECT OF SHADANGA GUGGULU IN THE MANAGEMENT OF KATIGRAHA 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 KAVERI PATIL |
| Designation |
PG SCHOLAR |
| Affiliation |
MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES |
| Address |
Outpatient department of Kayachikitsa,Room no 4,Ground floor, Muniyal instutute of ayurveda medical sciences,manipal,udupi, Karnataka.576104
Udupi
KARNATAKA
576104
India |
| Phone |
9110411790 |
| Fax |
|
| Email |
kaverivpatil27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PROF SHRIPATHI ACHARYA G |
| Designation |
Professor and Head of department |
| Affiliation |
MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES |
| Address |
Outpatient department of Kayachikitsa,Room no 4,Ground floor, Muniyal instutute of ayurveda medical sciences,manipal,udupi, Karnataka.576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845387720 |
| Fax |
|
| Email |
shripathi_acharya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR KAVERI PATIL |
| Designation |
PG SCHOLAR |
| Affiliation |
MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES |
| Address |
Outpatient department of Kayachikitsa,Room no 4,Ground floor, Muniyal instutute of ayurveda medical sciences,manipal,udupi, Karnataka.576104
Udupi
KARNATAKA
576104
India |
| Phone |
9110411790 |
| Fax |
|
| Email |
kaverivpatil27@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES |
| Address |
Muniyal instutute of ayurveda medical sciences,manipal,udupi, Karnataka.576104 |
| 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 KAVERI PATIL |
Muniyal institute of ayurveda medical sciences, manipal |
Outpatient department of Kayachikitsa,Room no 4,Ground floor, Muniyal instutute of ayurveda medical sciences,manipal,udupi, Karnataka.576104
Udupi
KARNATAKA |
9110411790
kaverivpatil27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| muniyal institute of ayurveda institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHADANGA GUGGULU, Reference: Rasaratna samucchaya, chapter 21st, verse 147, Route: Oral, Dosage Form: Guggulu , Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: TRAYODASHANGA GUGGULU , Reference: Cakradatta in chapter-22 (Treatment of Vatavyadhi), verses 72th to 75th., Route: Oral, Dosage Form: Guggulu , Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having clinical features of Katigraha.
2.Clinically diagnosed cases of Katigraha (Lumbar Spondylosis) will be taken for the study.
3.Patient of age group 18 to 60years (irrespective of sex)
|
|
| ExclusionCriteria |
| Details |
1.Patients having complicated diseases like malignant conditions of Spine, tuberculosis of spine.
2.Patients with history of trauma to the spine and with marked deformities of spinal cord and disc prolapse.
3.Gouty Arthritis, Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in intensity of pain and stiffness. |
30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in tenderness, Improvement in ROM |
30th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
13/04/2026 |
| 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="4"
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
|
This randomized controlled clinical study aims to evaluate the therapeutic effect of oral administration of Shadanga Guggulu in the management of Katigraha, with special reference to Lumbar Spondylosis. Lumbar Spondylosis is characterized by degenerative changes in the lumbar spine, marked by the formation of osteophytes. Patients with lumbar spondylosis typically experience lower back pain and restricted movement, primarily due to age and work relatewd factors like lifting, carrying, maintaining poor posture. Katigraha, a Vata-dominant disorder described in classical Ayurvedic texts such as Gadanigraha and Madhava Nidana, clinically correlates with lumbar spondylosis. Shadanga guggulu mentioned in Rasaratna Samuchaya which contains drugs having Vatahara, Shothahara, Shulaprashamana properties. The study aims to scientifically validate the effectiveness of Shadanga Guggulu as a potential Ayurvedic management option for Lumbar Spondylosis. |