| CTRI Number |
CTRI/2025/12/099924 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
An open randomised clinical control study of add on effect of saindhavadi taila snehapana along with ashtakatavar tail matra basti in grudhrasi with special reference to sciatica |
|
Scientific Title of Study
|
An open Randomised clinial control study of Add on effect of Saindhavadi tail snehpana along with Ashtakatvar tail matra basti in Grudhrasi w.s.r.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 |
DrDevyani Vikas Bhadane |
| Designation |
PG Scholar |
| Affiliation |
R.A.Podar Govt(Ayu) college,Worli,Mumbai-18 |
| Address |
OPD NO.7 Panchakarma Department ,M.A.Podar Hospital,R.A.Podar Govt.(Ayu)college,Worli,Mumbai-18
Mumbai
MAHARASHTRA
400018
INDIA
Mumbai (Suburban)
MAHARASHTRA
400018
India |
| Phone |
9284195460 |
| Fax |
|
| Email |
devyanibhadane06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRajiv Tarpe |
| Designation |
Assistant professor |
| Affiliation |
R.A.Podar Govt(Ayu)college,Worli ,Mumbai-18 |
| Address |
OPD no.7 Panchakarma department,M.A.Podar Hospital,R.A.podar Govt.(Ayu)college,Worli ,Mumbai-18
Mumbai (Suburban)
MAHARASHTRA
400018
India |
| Phone |
7738387364 |
| Fax |
|
| Email |
rajivtarpe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRajiv Tarpe |
| Designation |
Assistant professor |
| Affiliation |
R.A.Podar Govt(Ayu)college,Worli ,Mumbai-18 |
| Address |
OPD no.7 Panchakarma department,M.A.Podar Hospital,R.A.podar Govt.(Ayu)college,Worli ,Mumbai-18
Mumbai (Suburban)
MAHARASHTRA
400018
India |
| Phone |
7738387364 |
| Fax |
|
| Email |
rajivtarpe@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.A.Podar Ayurvedic Hospital,Dr.Annie besant road ,Worli,Mumbai |
|
|
Primary Sponsor
|
| Name |
R.A.Podar Gov.(Ayu) College,Worli,Mumbai-18 |
| Address |
R.A.Podar Govt(Ayu)College,Worli,Mumbai-18 Dr.Annie Besant Road pin code-400018 |
| Type of Sponsor |
Government medical college |
|
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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 Rajiv Tarpe |
M. A. Podar Hospital Worli |
opd no 7 panchakarma department
Mumbai
MAHARASHTRA |
7738387364
rajivtarpe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS committee of institution, R. A. Podar Govt Ayurved College, worli |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Snehapana | (Procedure Reference: Ashtang hriday sutrasthan 16/18, Procedure details: empty stomach snehapana once a day)
(1) Medicine Name: Saindhavadi taila, Reference: Charak chikista 27/46, Route: Oral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | Matra basti | (Procedure Reference: charak siddhisthan 4/54, Procedure details: 1 mastra basti per day after food)
(1) Medicine Name: Ashtkatvar taila, Reference: chakradatta 24/12-13, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient indicated for snehapana as per classics.
2.Patient indicated for basti as per classics.
3.Patient having classical sign and symptoms of Grudhrasi
4.Both male and female of age 30-60 yrs are included
5.Degenerative changes evident on X-ray Ls spine |
|
| ExclusionCriteria |
| Details |
1 Patient unfit for shehapana as per classics
2 Patient unfit for basti as per classics
3 Fracture of Lumbar spine
4.Patient suffering from any systemic disease which will interfere in the treatement
5 Patient having Ano rectal bleeding,fistula |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
To evaluate subject for subjective symptoms like Ruja,Stambh,Spandana,Toda and Objective assesment for improving the LfM,LEM,SLRT in group of Saindhavadi tail snahapatana with Ashtkatvar tail matra basti
To evaluate subject subjective symptoms and objective assesment for improving in group of Ashtkatvar tail matra basti group
To compare subject subjective symptoms like ruja,stambha,spandan,toda and objective assesment for improving LFM,LEM,SLRT in between above two groups |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvment in Lumber flexion
Improvement in Lumber extensionI
Improvement in sign & symptoms of Grudhrasi |
21 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3 |
|
Date of First Enrollment (India)
|
16/01/2026 |
| 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="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
|
INTRODUCTION- Grudhrasi is describe in brihatrayi.it is a type of vatvyadhi,and symptoms of disease are Ruk,Toda and stambha is initially in sphik and radiates to kati,prishta,uru,janu,jangha and pada.it resembles with Sciatica. The sciatic nerve is longest nerve in human body .it originates from the vertebral column at the level of 4th lumbar to 3rd sacral vertebra and extends up to the feet. The causes of sciatica are arthritic changes in the L.S.spine,disc herniation in the level of L.S.Spine due to bad posture ,accidents ,sedentary lifestyle and repeatative stress injuries. This disease is very painful and sometimes it hampers the routine life of individual.the treatement mentioned in ayurveda texts is snehapana ,basti,upnaha,agnikarma,siravedha.
Saindhavadi taila is ushna,snigdha,vatanulomak in action. saindhavadi taila is indicated in Gridhrasi because gridhrasi is vata-kapha pradhan disorder where stiffness,pain radiating from kati to pada and stambha are seen.snehapana with saindhavadi taila helps by pacifying vitiated vata and kapha ,improving margavarana,reducing pain (ruja),stiffness(stambha)and nerve conduction. mode of action-by internal oleation ,it lubricates srotas ,breaks down avarana of kapha over vata and facilitates proper gati of vata.
NEED OF STUDY- Prevalnce rate of Sciatica is 5% To reduce the prevalnce rate of Sciatica. To enhance the use of ayurvedic manegement in painful condition of Sciatica.
NUMBAR OF PATIENTS- Group A-study group-32 patients for snehapana along with matrabasti Group B-control group-32 patients for matra basti
INVESTIGATIONS- CBC,ESR,Lipid profile,RA,X ray L.S.Spine,uric acid
SUMMARY AND CONCLUSION- The work will be summarized to make final conclusions ,observations of results will be concluded with statistical analysis under the heading ,Conclusion with explanation at the end of whole research.
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