CTRI Number |
CTRI/2025/03/083066 [Registered on: 21/03/2025] Trial Registered Prospectively |
Last Modified On: |
20/03/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Diagnostic Screening |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Efficacy of Murchita tila taila Anuvasana basti in Gridhrasi |
Scientific Title of Study
|
A comparative clinical study to assess the efficacy of Murchita tila taila anuvasana basti with avapa dravya and without avapa dravya in the management of Gridhrasi Vis A vis Sciatica |
Trial Acronym |
Yes |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr ANNAPOORNA K P |
Designation |
2ND YEAR PG SCHOLAR |
Affiliation |
Ayurveda Mahavidyalaya college and Hospital |
Address |
AYURVEDA MAHAVIDYALAYA COLLEGE AND HOSPITAL HUBLI KARNATAKA 580024 OPD 2 OPD 2 Department of Panchakarma Ayurveda Mahavidayalaya College and Hospital Heggeri extension old hubli Hubballi 580024 Dharwad KARNATAKA 580024 India |
Phone |
07619421408 |
Fax |
|
Email |
annapoornakp44@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR HARISH KULKARNI |
Designation |
PROFESSOR |
Affiliation |
Ayurveda Mahavidyalaya college and Hospital |
Address |
PANCHAKARMA OPD NO 2 Ayurveda Mahavidyalaya college and Hospital Heggeri extension old Hubli Hubballi 580024 OPD NO 2 Department of Panchakarma Ayurveda Mahavidyalaya college and Hospital Heggeri extension old hubli Hubballi 580024 Dharwad KARNATAKA 580024 India |
Phone |
9448501900 |
Fax |
|
Email |
harishpk2007@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr ANNAPOORNA K P |
Designation |
2ND YEAR PG SCHOLAR |
Affiliation |
Ayurveda Mahavidyalaya college and Hospital |
Address |
PANCHAKARMA OPD NO 2 Ayurveda Mahavidyalaya college and Hospital Heggeri extension old hubli Hubballi 580024 OPD 2 Department of Panchakarma Ayurveda Mahavidayalaya College and Hospital Heggeri extension old hubli Hubballi 580024 Dharwad KARNATAKA 580024 India |
Phone |
7619421408 |
Fax |
|
Email |
annapoornakp44@gmail.com |
|
Source of Monetary or Material Support
|
AYURVEDA MAHAVIDYALAYA COLLEGE AND HOSPITAL HEGGERI EXTENSION OLD HUBLI HUBBALLI KARNATAKA INDIA 580024 OPD 2 DEPARTMENT OF PANCHAKARMA |
|
Primary Sponsor
|
Name |
DR ANNAPOORNA K P |
Address |
OPD 2 Department of panchakarma Ayurveda Mahavidyalaya college and Hospital Heggeri extension old hubli Hubballi 580024 |
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 ANNAPOORNA K P |
Ayurveda Mahavidyalaya college and Hospital |
OPD 2 Department of Panchakarma Ayurveda Mahavidyalaya college and Hospital Heggeri extension old hubli Hubballi 580024
Dharwad KARNATAKA |
07619421408
annapoornakp44@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethical committee Ayurveda Mahavidyalaya college and Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M518||Other thoracic, thoracolumbar andlumbosacral intervertebral disc disorders. Ayurveda Condition: GRUDHRASI, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | anuvAsana-bastiH, अनुवासन-बस्तिः | (Procedure Reference: SHARAGANDHARA UTTARAKHANDA 5TH CHAPTER , Procedure details: MURCHITA TILA TAILA ANUVASANA BASTI WITH SAINDHAVA LAVANA AND SHATAPUSHPA AS AVAPA DRAVYA) (1) Medicine Name: MURCHITA TILA TAILA SAINDHAVA LAVANA SHATAPUSHPA , Reference: SHARANGDHARA UTTARAKANDA 5TH CHAPTER , Route: Rectal, Dosage Form: Taila, Dose: 144(ml), Frequency: od, Duration: 11 Days | 2 | Comparator Arm | Procedure | - | anuvAsana-bastiH, अनुवासन-बस्तिः | (Procedure Reference: SHARANGDHARA UTTARAKANDA 5TH CHAPTER, Procedure details: MURCHITA TILA TAILA ANUVASANA BASTI WITH RASNA AND VACHA AS AVAPA DRAVYA ) (1) Medicine Name: MURCHIT TILA TAILA RASNA VACHA, Reference: SHARANGDHARA UTTARA KANDA 5TH CHAPTER, Route: Rectal, Dosage Form: Taila, Dose: 144(ml), Frequency: od, Duration: 11 Days | 3 | Comparator Arm | Procedure | - | anuvAsana-bastiH, अनुवासन-बस्तिः | (Procedure Reference: SHARANGHADARA UTTARAKANDA 5TH CHAPTER , Procedure details: MURCHITA TILA TAILA ANUVASANA BASTI WITHOUT ANY AVAPA DRAVYA) (1) Medicine Name: MURCHITA TILA TAILA, Reference: SHARANGDHARA UTTARAKANDA 5TH CHAPTER, Route: Rectal, Dosage Form: Taila, Dose: 144(ml), Frequency: od, Duration: 11 Days |
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
1Subjects with symptoms of radiating pain from Sphik (Buttock) and Kati (Lumbar region) to Prishta (Back) Uru (Thigh)Janu (Knee) Jangha (Calf region) and Pada (Feet)
Subjects between age group 20-80 years of either sex
Subjects of both Vataja and Vata Kaphaja Gridhrasi will be considered for the study
Subjects who are fit for Basti Karma will be included after proper evaluation of vitals
Chronicity less than 5 years without any deformity and complications |
|
ExclusionCriteria |
Details |
Basti Ayogya
Subjects not willing to give informed consent
Subjects with evidence of congenital anomalies of the spine Tuberculosis of spine Traumatic fracture Neoplasms Epidural abscess and others will be excluded after proper examination
Diagnosed cases of Systemic disorders like chronic heart disease chronic renal failure and chronic liver disease which may interfere with the course of the treatment
Pregnancy |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Other |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in pain stiffeness pulsating numbness |
11 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Heaviness anorexia |
11 days |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
02/04/2025 |
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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [annapoornakp44@gmail.com].
- For how long will this data be available start date provided 02-04-2025 and end date provided 02-04-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
|
6.1 NEED FOR THE STUDY: Panchakarma forms the basis of purificatory therapy in Ayurveda. In more precise sense, Panchakarma is nothing other than the strongest transcellular bio-purificatory mechanism ever evolved. Movement is the sign of radiant life but unfortunately in some clinical conditions this vital factor is affected and such person feels himself as miserable creature as he has to depend on others for his daily activities. Gridhrasi is one such disorder where in these locomotor functions are affected. It is one among Vataja Nanatmaja Vikara. Pain radiating from Sphik (Waist) and extends to leg in the order as Kati(Low back ), Prishta (Buttocks), Uru(Thigh), Janu (Knee), Jangha (Calf), and Pada (Foot)1. Vataja Gridhrasi is characterized by Sthambha(Stiffness), Ruk(Pain), Toda(Pricking pain), Muhurmuhuspandana(Pulsating pain) Sphurana(Throbbing pain) and Sthabdtha(Stiffness) of Janu ,Jangha, Uru, are Predominant . In Vatakaphaja Gridhrasi Gaurava(Heaviness), Arochaka(Anorexia), Tandra(Drowsiness) are predominant.2 Sciatica resembles the disease Gridhrasi of Ayurveda. It causes excruciating pain which radiates through the pathway of sciatic nerve. Here Piercing type of pain is present which restricts the movement of affected leg. The gait resembles with that of bird vulture. About 80-90% of people get affected by low back pain. In general, an estimated 5-10% of patients with low back pain have sciatica, whereas the life time prevalence of low back pain ranges from 49% to 70%. The Annual prevalence of disc related sciatica in the general population is estimated at 2.2%. A few personal and occupational risk factors for sciatica have been reported, including age, height, mental stress, smoking, and exposure to vibration from vehicles. Evidence for an association between sciatica and sex or Physical fitness is conflicting.3 Basti is one among Panchakarma procedures and it is the best treatment for most of the Vatavyadhi as quoted by Maharshi Charaka that “Basti Vataharanam Shrestham”. 4 It claimed as the main radical aspect of Chikitsa seeking the absolute cure of disease by eliminating its root cause. Acharya Charaka consider Basti as “Ardhachikitsa.” 5 It is advocated as the best and quickest way to provide strength and immunity to even children and old people. Siravyadha, Basti Karma and Agni Karma are considered as the treatment of choice in the management of Gridhrasi.6 Basti being one of the main treatment, plays a major role in mitigating vitiated Vata and thus relieves the Pain in Gridhrasi. Ruksha Guna plays a vital role in producing vitiation of Vata which can be tackled by Sneha Guna due to their opposite nature. Anuvasana is a type of Snaihika basti and it can be used as a single therapy for various Vataja Vikaras. 4 Tila taila is best among Sthavara Sneha and it is Bruhmana, Balakara, and Vatashamaka7. Due to Snigdha, Guru, Sookshma, Ushna Guna it acts on Vata and Kapha dosha. Three Phala is generally been considered as the fixed dosage of Anuvasana Basti according to Acharya Gayadasa. But it is observed that the Sneha Matra does not get retained as much as it is desired for 3 Yama. Hence Acharyas mentioned many Avapa or Prakshepaka Dravyas to be used in Basti Dravya. According to Chakrapani “Avapasthuanuvasaneapi Satahvadinam karthvya eva” in Anuvasana Basti , Satahva etc are used as Avapa8. Sarngadhara mentioned Saindhava lavana, Shatapushpa, Rasna, Vacha, Devadaru ,Kusta as Avapa Dravya used in Anuvasana Basti. No previous research work was done on Anuvasana Basti with Avapa Dravya and without Avapa Dravya. Hence, an attempt will be made to assess the efficacy of Anuvasana Basti with Avapa Dravya and without Avapa Dravya on retention time and on different subjective and objective parameters . |