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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  
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 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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-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
2Comparator ArmProcedure-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
3Comparator ArmProcedure-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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. 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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [annapoornakp44@gmail.com].

  6. 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.

  7. 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 .
 
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