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 -  Statistical Analysis Plan
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [shreegouri2808@gmail.com].
   


6. For how long will this data be available start date provided 10-08-2024 and end date provided 10-08-2025?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

INTRODUCTION- Ayurveda has mainly two aspects of Chikitsa i.e. Shodhana chikitsa and Shamana chikitsa. Shodhana therapy for the purification of body, by which the accumulated morbid Dosha responsible for the disease is expelled out to produce proper functioning of the body but this therapy is not economical, patient have to follow so many diet regimens. In today’s lifestyle patient is not easily convinced for Shodhana therapy because of time limitation. Shamana snehapana is a unique method of internal administration

of Sneha. It is a procedure that pacifies the doshas in their site . It is is more convenient, economical, less time consuming, easy to carryout at OPD level.

 Acharya Chakradatta and Bhavaprakasha opines that, Gridhrasi can be managed by oral administration of  Eranda taila with Gomutra for 1 month. Eranda Taila as Shamana Snehapana processes  Guru, Snigdha, Ushna, Sara Guna and VataKaphahara in nature.  Gomutra  along with Eranda taila as Anupana, possess properties like Laghu, Ruksha, Teekshna and  Ushna.

OBJECTIVES OF THE STUDY

PRIMARY OBJECTIVE

·       To evaluate the efficacy of Shamana Snehapana of Eranda taila with Gomutra in Gridhrasi w.s.r Sciatica

SECONDARY OBJECTIVE

·       To study Gridhrasi in detail.

·       To study Shamana Snehapana in detail.

 RESEARCH QUESTION

H₀ - There is no effect of Shamana Snehapana of Eranda taila  with  Gomutra  in Gridhrasi

 H_{1 -} There is significant effect of Shamana Snehapana of Eranda taila with Gomutra in Gridhrasi.     

 REVIEW OF LITERATURE

 DISEASE REVIEW

          According to Acharya Charaka, Gridhrasi is one among the 80 Vataja Nanatmaja vyadhi¹ and he mentioned 2 types- Vataja Gridhrasi and VataKaphaja Gridhrasi. Vataja Gridhrasi Lakshanas are  Sthambha, Ruk, Toda, and Spandana⁸ . VataKaphaja Gridhrasi Lakshanas are Tandra, Gourava, Aruchi along with Lakshanas of Vataja Gridhrasi⁹.

  TREATMENT REVIEW

             Eranda Taila as Shamana Snehapana processes  Sara, Guru, Snigdha, Ushna Guna and VataKaphahara in nature⁶.  Gomutra  along with Eranda taila as Anupana, possess properties like Ruksha, Teekshna and  Ushna⁷.

             Acharya Chakradatta and Acharya Bhava Prakasha mentioned Eranda taila prayoga with gomutra in the form of Shamananga Snehapana for 30 days in the management of Gridhrasi. 

  METHODOLOGY

 STUDY DESIGN - Randomized clinical study, Open label method.

 SAMPLE SIZE - Minimum 30 patients with classical Lakshanas of Gridhrasi will be randomly selected irrespective of religion, sex, and occupation.

 SOURCE OF DATA

A] Subject Source-

     Patient diagnosed with signs and symptoms of Gridhrasi will be selected from OPD and IPD of K.V.G Ayurveda Medical College and hospital, Sullia.

B] Literary Source-

     Literary aspect of study will be collected from Ayurvedic classics and modern text books and will be updated with recent medical journals and internet.

C] Drug Source-

     Eranda taila used in this clinical trial is obtained from GMP certified company and Gomutra arka from K.V.G Ayurveda pharma and research centre , Sullia.

SELECTION CRITERIA

A] DIAGNOSTIC CRITERIA

Diagnosis will be established by cardinal signs and symptoms of  Gridhrasi that are mentioned in classical such as;

·       Sthamba

·       Ruk

·       Toda

·       Spandana

·       Sakthi- Utkshepa- Nigraha

·       Tandra

·       Gourava

·       Arochaka

B] INCLUSION CRITERIA

1)     Patients between the age of 20 and 70 years.

2)     Patients with classical symptoms of  Gridhrasi.

3)     Patients who are Shamana Snehapana yogyas.

C] EXCLUSION CRITERIA

1)     Patients below 20 years and above 70 years will be excluded.

2)     Pregnant and lactating women will be excluded.

3)     Associated with any other systemic disorders will be excluded.

4)     Shamana Snehapana Ayogyas.

D] PROCEDURE

Purva Karma

Patient is advised to take warm and light foods on previous night of Snehapana, Sneha is given after attending the natural urges of bowel and bladder.

Pradhana Karma

The patient is instructed to wash his mouth with warm water and two Karsha (10 ml) of Eranda taila with two Karsha (10ml) of  diluted Gomutra arka. (5ml of Gomutra arka will be diluted with equal quantity of warm water) is taken in a steel glass and given to the patient during the morning hours approximately in between 8-9 at regular time of food intake when the patient feels hungry. Patient is advised to close both eyes and nostrils to avoid aversion towards smell and sight of Taila. This procedure is repeated for 30 days.

Paschat Karma

            Patient is advised to take hot water if he/she feels thirsty. Patient is also advised to take food when he/she feels hungry. Day sleep is strictly prohibited and light and warm food is advised.    

  Study duration and follow up:

     Study duration : 30 days

     Follow up : 7 days

     Total duration : 37 days

 Observation period:

      Initially on 1^st day before treatment

      On 30^th day after treatment

      37^th day for the last assessment.

 Assessment criteria:

      The Subjective and Objective parameters of pre and post treatment will be compared for assessment of results.

 Subjective Parameters:

 Sthamba [stiffness]

 Ruk [pain]

 Toda [pricking pain]

 Spandana [ fasciculation]

 Suptata [ numbness]

 Gaurava [heaviness]

 Arochaka [ anorexia]

 Bhuktadwesha [ Aversion towards food]

 Objective Parameters:

      Straight leg raise test [SLR]

Oswestry disability index score [ ODI]

Schober’s test

 Posology

Eranda taila- Two Karsha [ 10ml]

Gomutra Arka mixed with equal quantity of Hot water - Two Karsha

[ 10ml]