| CTRI Number |
CTRI/2025/07/092060 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Lowback pain radiating to legs |
|
Scientific Title of Study
|
AN OPEN LABELLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE COMBINED EFFECT OF ASHTAVARGA BASTI FOLLOWED BY SIRAVYADHA AND ASHTAVARGA BASTI FOLLOWED BY AGNIKARMA IN 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 |
Dr Malathi S |
| Designation |
Panchakarma Post Graduate Scholar |
| Affiliation |
Taranath Government Ayurveda Medical college and hospital |
| Address |
Taranath govt ayurveda medical collage and hospital dr rajkumar road ballari ,Department of Panchakarma,room no -6
Bellary
KARNATAKA
583101
India |
| Phone |
9740878723 |
| Fax |
|
| Email |
malathis311299@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh sugur |
| Designation |
Proffesor and Head of department |
| Affiliation |
Taranath Government Ayurveda Medical college and hospital |
| Address |
Taranath govt ayuerveda medical collage and hospital dr rajkumar road ballari ,Department of panchakarma ,room no -6
Bellary
KARNATAKA
583101
India |
| Phone |
9844457833 |
| Fax |
|
| Email |
vdrsugur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Malathi S |
| Designation |
Panchakarma Post Graduate Scholar |
| Affiliation |
Taranath Government Ayurveda Medical college and hospital |
| Address |
Taranath government ayuerveda medical collage and hospital dr rajkumar road ballari,
Department of panchakarma ,
room no -6
Bellary
KARNATAKA
583101
India |
| Phone |
9740878723 |
| Fax |
|
| Email |
malathis311299@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of PG studies in panchakarma,
room 6,Taranath government ayurveda Medical college and hospital,Dr Rajkumar road ,Ballary-583101 |
|
|
Primary Sponsor
|
| Name |
Pandit Taranath Government Ayurveda Medical college and hospital ballari |
| Address |
Department of PG studies in panchakarma, Pandit Taranath Government Ayurveda Medical college and hospital ballari, Karnataka 583101 |
| Type of Sponsor |
Government medical college |
|
|
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 Malathi S |
Taranath government ayurvedic medical college ballari |
Department of PG studies in panchakarma,Room no 6,Taranath govt ayurvedic medical college and hospital dr rajkumar road ballari,Karnataka 583101
Bellary
KARNATAKA |
09740878723
malathis311299@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Taranath Government Ayurveda Medical College Institutional Ethical Committee |
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:G00-G99||Diseases of the nervous system. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म followed by Agnikarma | (Procedure Reference: Charaka chikistasthana 28 chapter, Procedure details: : Basti Purvakrma -Deepan Pachana with Ajamoda churna ( 3-5 gms ) 3 times/day–before food. Kosta shodana with Murchitha Eranda Tailam. Dose-40-70ml According to the koshta. Anupana-Ushna jala.In Pittakala. Pradhana karma -Astavarga siddha kala basti Paschat karma -Hasta, Pada Maranda & Sphik Tadana. Ushna Jala Snana followed by Laghu Bhojana.
Agnikarma -
Purvakarma -Snigdha,Picchila Ahara Sevana
Dhavana with Triphala kashaya,
Pradhana karma -Agnikarma as Bindu Dahana (3-4 points) at tender area of Lumber-Sacral Spine in course of Sciatic nerve with Tamra Shalaka for 2 Sittings (1st after Basti Karma & 2 nd sitting after 7 days).
Paschat karma -Ghrita Application over the dagdha vrana
)
| | 2 | Intervention Arm | Procedure | - | bastikarma/v बस्तिकर्म/वस्तिकर्म followed by Sirvyadha | (Procedure Reference: Charaka chikisthana 28 chapter, Procedure details:
Basti
Purvakrma -Deepan Pachana with Ajamoda churna ( 3-5 gms )
3 times/day–before food.
Kosta shodana with Murchitha Eranda Tailam.
Dose-40-70ml According to the koshta.
Anupana-Ushna jala.In Pittakala.
Pradhana karma -Astavarga siddha kala basti
Paschat karma -Hasta, Pada Maranda & Sphik Tadana.
Ushna Jala Snana followed by Laghu Bhojana
Siravydha -
Purvakarma -
ila Yavagu sevana for 2 Days,
Sthanika Abhyanga with Murchita tila taila followed by Nadi Sweda
Pradhana karma -Siravyadha on antara kandara gulpha sandhi -2 Sittings (1st after Basti Karma & 2 nd sitting after 7 days)
Paschat karma -Snigdha,Ushna, Drava Ahara
Sthanika Abhyanga for Udara, Kati, Urupradesha with Murchita Tila Taila followed by Patra Pinda Sweda.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria of Gridhrasi
Patients fit for Basti karma, Siravyadha and Agnikarma
|
|
| ExclusionCriteria |
| Details |
Patients with evidence of congenital anomalies of the spine, Spinal tuberculosis, Neoplasm, Traumatic fracture and Epidural abscess
Patients Where surgical intervention is Needed.
Patients with other systemic disorders.
Pregnant & lactating women
Subjects with HIV & HBs Ag positive
Patents with low Hb% and abnormal bleeding time and clotting time value
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Imrovement in signs and symptoms of gridhrasi(Sciatica) |
31 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/08/2025 |
| 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="1"
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
|
1 NEED FOR THE STUDY :
Gridhrasi is one among the Vataja Nanatmaja vyadhi affecting
the locomotor system in which pain is major symptom. The Name itself indicates
the way of gait shown by the patient due to the extreme pain is just like a
Gridhah (vulture). In Gridhrasi intense shooting pain starts from Sphik
pradesha and Radiates to Kati, prusta, uru, janu, jangha and pada in which
patient is unable to walk properly.
On
the basis of symptoms of Gridhrasi, it can be equated with the disease
Sciatica. It occurs due to the spinal nerve irritation & characterized by
pain in lower back region that Radiates downwards up to foot in distribution of
sciatic nerve.In our Samhita’s, The line of management include Basti,
Siravyadha & Agnikarma4,As vata involvement is evident with or
without kapha dosha due to pain and disability. Snehana & Swedana are also
advised as a treatment.
Basti
is considered as Ardha chikitsa as per Acharya Charaka ,Vagbhata. It
removes the vitiated dosha situated in the body from Padatalamoordha.Basti is
administered with Ashtavarga kashaya dravya which is having a properties like
Anilapaha and Shulaprashamana.
Acharya
Sushruta has mentioned diseases those are not relieved by Snehadi, lepanadi
measures. In this situation, the Siravyadha is an emergency management to
achieve for the better results. As Samyak Siravyadha are Laghavam and
Vedanashanti, the pain arising from a disease condition get subsided, So
Siravyadha can be used in pain predominent diseases. More over, the siravedhana
is also accepted as half of the therapeutic measures like Basti.
Acharya Sushruta and Vagbhata mentioned
Agnikarma in Asthi , Sandhi and Snayugata vata vyadhi.As here
Gridhrasi is a Snayugata vata vyadhi in which Sthamba and Ruk are the
predominant symptoms, which disturb the normal routine of the persons , which
is effectively relieved by Agnikarma.
Various References shows that, the
diseases treated with Agnikarma do not re-occur and their is no fear
of putrification & bleeding and also yeilds quick relief.
Hence
my study is entitled as AN OPEN LABELLED COMPARATIVE CLINICAL STUDY TO
EVALUATE THE COMBINED EFFECT OF ASHTAVARGA BASTI FOLLOWED BY SIRAVYADHA AND
ASHTAVARGA BASTI FOLLOWED BY AGNIKARMA IN GRIDHRASI
W.S.R TO SCIATICAis undertaken.
|