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CTRI Number  CTRI/2024/08/072393 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 04/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Procedure]  
Study Design  Single Arm Study 
Public Title of Study   To know the effect of Karaskara Ghritha Matrabasti in Vataja Gridhrasi 
Scientific Title of Study   A Clinical Trial to evaluate the effect of Matra Basti with Karaskara Ghritha in Vataja Gridhrasi (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 Abirami D 
Designation  2nd Year PG Scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department of Panchakarma Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  8148080612  
Fax    
Email  abidhina1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chitta Ranjan Das 
Designation  Professor 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department of Panchakarma Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  9444123506  
Fax    
Email  drcrdayu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abirami D 
Designation  2nd Year PG Scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Department of Panchakarma Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  8148080612  
Fax    
Email  abidhina1998@gmail.com  
 
Source of Monetary or Material Support  
Sri Jayendra Saraswathi Ayurveda College and Hospital, Chennai - Bangalore Highway, Nazarathpet, Chennai - 600123 
 
Primary Sponsor  
Name  Dr Abirami D 
Address  Department of Panchakarma Sri Jayendra Saraswathi Ayurveda College and Hospital Bangalore - Chennai Highway, Nazarathpet, Chennai - 600123 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abirami D  Sri Jayendra Saraswathi Ayurveda College and Hospital  Department Of Panchakarma Chennai Bangalore Highway
Thiruvallur
TAMIL NADU 
8148080612

abidhina1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital, Department of Ayurveda of SCSVMV, Nazarathpet, Chennai - 600123  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M544||Lumbago with sciatica. Ayurveda Condition: GRUDHRASI (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charaka Samhita, Procedure details: 9 days of procedure )
(1) Medicine Name: Karaskara Ghritha, Reference: Sahasrayogam, Route: Rectal, Dosage Form: Ghrita, Dose: 72(ml), Frequency: od, Duration: 9 Days
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients between 35 to 70 years of age of either sex
Patients having symptoms of radiating pain from Sphik to Kati, Prushta, Uru, Janu, Jangha ad Pada
Patients who are fit for Matrabasti karma
 
 
ExclusionCriteria 
Details  Patients who are unfit for Matrabasti karma
History of traumatic conditions of spine
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction of low back pain, numbness, radiating pain, pricking pain
 
on 18th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Lumbar Range of movements
 
60 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/09/2024 
Date of Study Completion (India) 08/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  
Basti is one of the Panchakarma procedures where medicated oils or decoctions are administered through anal route. It acts directly at the site of Vata Dosha i.e., Pakvashaya and thereby indicated in all Vatavyadhi. Matra Basti is one of the types where medicated Sneha is administered at least dosage. It can be administered to all patients in all seasons and has no complications. It is very convenient in present day life. Gridhrasi, one of the 80 Nanatmaja Vata Vyadhis is of 2 types – Vataja Gridhrasi and Vatakaphaja Gridhrasi. The cardinal features of Vataja Gridhrasi are pain initially in Sphik radiating to Kati, Prushta, Uru, Janu, Jangha and Pada along with Stambha, Toda, Spandanam, difficulty in lifting the leg (Sakthi Utkshepa Nigraha), bending of body, numbness of the knee, waist and thigh joints. Basti Karma, Agni Karma and Siravyadhana are considered as the choices of treatment in Vataja Gridhrasi. Matra Basti which is Vatahara, Balya and Brumhana administered for 9 days reaches till Majja Dhatu and thereby pacifies Vata Dosha at the site of cause. Sciatica which is a debilitating condition in which pain radiates from the low back into the buttock and along the posterior or lower aspect of the lower limb. About 80-90% of the people get affected by low back pain and 5% of those become victims of sciatica. The most common cause of sciatica is a herniated or bulging lumbar intervertebral disc. Karaskara Ghritha consists of Shodhita Karaskara Beeja, Kadaliphala, Yashtimadhu, Draksha, Ikshurasa, Balamoola, Goksheera processed in Goghritha. It is indicated in Sandhi Roga and Vatarakta. In the Samprapti of Vataja Gridhrasi, Sira, Kandara and Snayu are involved which infers the involvement of Rakta dhatu. Karaskara Ghritha possesses Madhura rasa, Guru, Snigdha Guna, Sheeta Virya and Vatapittahara properties predominantly may be potentially beneficial in Vataja Gridhrasi. It has been administered clinically through anal route and found effective in Gridhrasi because of its Vedhana Shamaka Karma and nervine tonic property. So here a study is attempted to assess the effect of Matra Basti with Karaskara Ghritha in Vataja Gridhrasi (Sciatica).

 
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