| CTRI Number |
CTRI/2026/01/102206 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The treatment of Mulakadi yoga basti in Sciatica |
|
Scientific Title of Study
|
A CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECT
OF MULAKADI YOGA BASTI IN THE TREATMENT OF GRIDHRASI
WSR 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 G M Pooja |
| Designation |
PG Scholar |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic medical college koppal |
| Address |
OPD no-04, Department of Panchakarma, Shree Jagadguru Gavisiddeshwara Ayurvedic medical College, Koppal.
OPD no-04, Department of Panchakarma, Shree Jagadguru Gavisiddeshwara Ayurvedic medicalCollege, Koppal.
Koppal
KARNATAKA
583231
India |
| Phone |
9353259401 |
| Fax |
|
| Email |
poojagm4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Hakkandi |
| Designation |
Professor |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College, Koppal |
| Address |
OPD no-04, Department of Panchakarma, Shree Jagadguru Gavisiddeshwara Ayurvedic medical College, Koppal.
OPD no-04, Department of Panchakarma, Shree Jagadguru Gavisiddeshwara Ayurvedic medical College, Koppal.
Koppal
KARNATAKA
583231
India |
| Phone |
9448609362 |
| Fax |
|
| Email |
sureshhakkandi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Hakkandi |
| Designation |
Professor |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College, Koppal |
| Address |
OPD no-04, Department of Panchakarma, Shree Jagadguru Gavisiddeshwara Ayurvedic medical College, Koppal.
OPD no-04, Department of Panchakarma, Shree Jagadguru Gavisiddeshwara Ayurvedic medical College, Koppal.
Koppal
KARNATAKA
583231
India |
| Phone |
9448609362 |
| Fax |
|
| Email |
sureshhakkandi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr G M Pooja |
| Address |
Department of Panchakarma ,Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College, Koppal |
| Type of Sponsor |
Other [Dr. G M Pooja] |
|
|
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 G M Pooja |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Koppal |
Panchakarma Unit Room no. 4 , SJGAMC & H Koppal 583231
Koppal
KARNATAKA |
9353259401
poojagm4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Koppal13 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vaitarana Basti, Reference: Chakradatta, Route: Rectal, Dosage Form: Kwatha/ Kashaya, Dose: 324(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mulakadi Yoga Basti, Reference: Vangasena samhita, Route: Rectal, Dosage Form: Taila, Dose: 480(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: nil |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with presenting features of Gridhrasi.
Subjects age between 20 to 60 years of either gender.
Subjects fit for Basti karma. |
|
| ExclusionCriteria |
| Details |
History of traumatic and infectious conditions of spine.
Systemic disorders that interferes with the course of treatment.
Pregnant and lactating women.
Subjects with Uncontrolled Diabetes mellitus and Uncontrolled HTN. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced Pain And Increased ROM |
Total Treatment duration- 8 days for Both Groups
Follow Up Duration- 16 days
Total Study Duration - 24 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 4 |
|
Date of First Enrollment (India)
|
15/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
Humans are the only animals that have evolved to stand and walk upright on two legs,characteristic
known as bipedalism. This unique ability is largely due to adaptations in the human skeleton particularly
the shape of spine, pelvis and lower limbs. Bipedalism has several advantages, such as freeing the hands
for carrying objects and improving visibility over tall grasses, but it also plays unique stresses on the spine
and back compared to the posture of quadrupedal animals. Low back pain is one of the common
conditions of locomotor system disorder; it affects people during their productive life. About 40 percent cases
of low back pain are radicular in origin and are considered under sciatica. It is a pain dominant life style
disorder which affects human activity considerably in terms of personal as well as social and professional
life. The condition resembles the disease Gridhrasi in Ayurveda.
Gridhrasi is a shoola pradhana vataja nanatmaja vyadhi. Gridhrasi the name itself
indicates like Gridhra vulture gait .The cardinal signs and symptoms are Ruk, Stambha, Toda,
Spandana, ,Tandra ,Gourava in the Sphik , Kati, Prushta, Uru, Janu, Jangha, and Pada. Worldwide
annual incidence of sciatica is percent whereas life time incidence is 10 percent to 40 percent. Sciatica is more common
between 30 to 50 years of age group. Men experience sciatica 3 times more than women. In modern medicine, administration of analgesics and physiotherapy will help to reduce
symptoms to certain extent but will not give permanent cure. Continuous use of such medicine cause
various side effects. Which further leads to surgery but again there are chances of Reoccurrence apart
from being expensive.Gridhrasi is caused predominantly due to vitiation of Vata or Vata kapha dosha. Basti is
the best treatment for vatavyadi and it is also indicated in Gridhrasi Chikitsa8. Vaitarana basti and
Mulakadi yoga basti are mentioned in the management of Gridhrasi. The Mulakadi yoga Basti is
having properties of Ushna Veerya, Vedana Sthapaka, Astiposhaka and Vatakapha hara and Vaitarana
basti possesses qualities of Srotoshodana and Vatakapha hara.
Based on this Randomised controll clinical study of Mulakadi Yoga Basti and
Vaitarana basti is taken for study. |