| CTRI Number |
CTRI/2025/02/079968 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical trial on the effect of two different drug sidha ksheer basti - Guduchi and Asthishrinkhala in patients of Katigraha |
|
Scientific Title of Study
|
A comparative clinical study on the efficacy of Guduchi Sidha Ksheer Basti and Asthishrinkhulum Sidha Ksheer Basti in the management of Katigraha w.s.r. 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 KHUSHBHU SHARMA |
| Designation |
PG SCHOLAR |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College ,Bhopal |
| Address |
P.G department of panchkarma ,OPD NO -5 ,Rani Dullaiya Smriti Ayurved PG Evam Chikitsalaya , Barkhedi kalan, Bhopal ,m.p.
Bhopal
MADHYA PRADESH
462004
India |
| Phone |
6264749017 |
| Fax |
|
| Email |
skhushbhu1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ATUL B PAWAR |
| Designation |
Professor & H.O.D IN Panchkarma department |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College and Hospital, Bhopal, M.P |
| Address |
P.G department of Panchakarma , O.P.D no - 05 , Rani Dullaiya Smriti Ayurved PG College and Hospital, Bhopal, M.P.
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
7499055336 |
| Fax |
|
| Email |
atul84pawar.ap.ap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ATUL B PAWAR |
| Designation |
Professor & H.O.D IN Panchkarma department |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College and Hospital, Bhopal, M.P |
| Address |
P.G.department of Panchkarma, O.P.D No -05 ,Rani Dullaiya Smriti Ayurved PG College and Hospital, Bhopal, M.P
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
7499055336 |
| Fax |
|
| Email |
atul84pawar.ap.ap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rani Dullaiya Smriti Ayurved Pg college and hospital ,BHOPAL,Madhya pradesh ,India 46044 |
|
|
Primary Sponsor
|
| Name |
Dr Khushbhu Sharma |
| Address |
PG Scholar , Panchkarma department,Rani Dullaiya Smriti Ayurved Pg College and Hospital ,Bhopal, Madhya pradesh , 462044 , India |
| 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 Khushbhu Sharma |
Rani Dullaiya Smriti Ayurved Hospital Bhopal |
OPD No 5, Department of Panchkarma, Rani Dullaiya Smriti Ayurved College and hospital, Bhopal , M.P
Bhopal
MADHYA PRADESH |
6264749017
skhushbhu1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Rani Dullaiya Smriti Ayurved PG College and Hospital, Bhopal, M.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: SAMANAVATAKOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Guduchi, Reference: Bhavprakash nighantu , madhyam khanda , 226- 228, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 120(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 16 Days, anupAna/sahapAna: No, Additional Information: -guduchi sidha ksheer basti will be given | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Asthishrinkhala , Reference: Bhavprakash nighantu , madhyam khanda ,8-10, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 120(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 16 Days, anupAna/sahapAna: No, Additional Information: asthishrinkhala sidha ksheer basti will be given |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed and confirmed cases of Kati -graha (Lumbar spondylosis ) as per Case report Form & on the basis of the sign & symptoms. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the pain & stiffness of the lower back . |
16 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Reduce the pain radiation and stiffness in the lower back.
2. Reduce the difficulty in walking. |
16 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a double group , open label , comparative clinical study on the efficacy of guduchi sidha ksheer basti and asthishrinkhulum sidha ksheer basti in the management of katigraha w.s.r. to lumbar spondylosis.the primary outcome is to reduce pain and stiffness of the lower back with relief in associated features will be measured by subjective and objective parameters. guduchi and asthishrinkhulum when sidha in ksheer can proved to be effective in treating dhatukshaya condition which caused katigraha . |