| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M544||Lumbago with sciatica. Ayurveda Condition: GRUDHRASIÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (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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