CTRI/2025/08/092736 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On:
09/08/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Role of Shampakadi Asthapana Basti with Patrapinda Sweda and Erandamooladi Niruha Basti with Patrapinda Sweda in Gridhrasi or Sciatica.
Scientific Title of Study
An open label randomized study to compare the efficacy of Shampakadi Asthapana Basti and Patrapinda Sweda with Erandamooladi Niruha Basti and Patrapinda Sweda In the management of Gridhrasi visa-A-vis 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 Manoj K P
Designation
Pg scholar
Affiliation
Sri Sri College Of Ayurvedic Science and Research hospital
Address
Room no-8, Panchakarma OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA
560082
India
Bangalore KARNATAKA 560082 India
Phone
8073142148
Fax
Email
manojkpayurveda@gmail.com
Details of Contact Person Scientific Query
Name
Dr Prarthana T
Designation
Associate professor
Affiliation
Sri Sri College Of Ayurvedic Science and Research hospital
Address
Room no-8, Panchakarma OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA
560082
India
Bangalore KARNATAKA 560082 India
Phone
9513180577
Fax
Email
drprarthana88@gmail.com
Details of Contact Person Public Query
Name
Dr Prarthana T
Designation
Associate professor
Affiliation
Sri Sri College Of Ayurvedic Science and Research hospital
Address
Room no-8, Panchakarma OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA
560082
India
Bangalore KARNATAKA 560082 India
Phone
9513180577
Fax
Email
drprarthana88@gmail.com
Source of Monetary or Material Support
Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA
560082
India
Primary Sponsor
Name
Dr Manoj k p
Address
Room no-8, Panchakarma OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA
560082
India
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 Manoj K P
Sri Sri College of Ayurvedic science and Research Hospital, Banglore
Room no-8, Panchakarma OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.
Bangalore
KARNATAKA
560082
India Bangalore KARNATAKA
(Procedure Reference: Panchakrma textbooka by B A Lohita, Procedure details: Poorvakarma : Herbal leaves will be cleaned & choped into small pieces. Round bottom wide mouthed vessel will be taken, grated coconut will be added in to it and fried till it turns to brown tinge. Add all the chopped leaves , Haridra Churna , Rasna Churna, Saindhava Lavana and 100 ml oil will be added to it and fried together. Fried leaves will be put on a piece of cotton cloth and tied them with a thick thread properly to make an ideal Pottali. Pottali should weigh approximately about 350 grams.
Pradhanakarma : The subject is made to lie down on Droni in supine position and relax . Sahacharadi Taila will be applied locally over the Katipradesha (lowerback), thighs and buttocks of the subject , then therapists massage the same areas by moving his palms in circular and linear fashion. The prepared Pottali is taken and heated in a vessel containing little amount of oil. When Pottali is properly heated , it will be taken out from vessel and temperature will be confirmed by touching it on the dorsum of the hand. Then its is applied to the subjects body by tapping the Pottali with continuous movement of the hand. In This way by maintaining the constant temperature of Pottali the procedure of Patrapinda Sweda will be continued for 20 minutes.
Paschatkarma: The subject will be advised to rest for 10 minutes. The part treated with PatraPinda Sweda will be wiped with towel.) (1) Medicine Name: Nirgundi, eranda , arka, chincha, dhatura, Reference: Panchakrma textbooka by B A Lohita, Route: Topical, Dosage Form: Not Applicable, Dose: 350(g), Frequency: od, Duration: 10 Days
2
Comparator Arm
Procedure
-
bastikarma, बस्तिकर्म
(Procedure Reference: charaka samhita, Procedure details: Poorvakarma: Niruha basti medicine is filled in enema can & kept ready. Patient will be advised to be on empty stomach, after ensuring the passing of motion, urine and flatus, patient will be made to lie down in supine position on the table. Sthanika Abhyanga will be performed followed by Sthanika Swedana done over lower abdomen, back, thighs and buttocks of the subject
Pradhankarma : With gloved hands therapist will smear oil ,to the tip of the catheter and anal orifice of the patient for lubrication with help of the cotton swab. Therapist will hold the enema can in the left hand and with the right hand catheter will be clamped artery forcep to prevent leakage. Then the catheter will be gently introduced into the anal canal in the direction of the spine for about 4 - 6 cms. Now Without shaking or trembling and with uniform pressure Niruha Basti will be administered by elevating the enema can and releasing medicine by releasing the clamp. Before the enema can becomes completely empty artery forceps will be once again clamped and the catheter will be withdrawn.
Paschatkarma : Gentle tapping over the buttocks will be done. Then patient will be asked to lie in supine position and rub his palms briskly against each other. At the same time the therapist will rub the soles vigorously followed by foot end elevation. Instructions will be given to pass the bowel after getting the Vega, followed by warm water bath and advised light diet.) (1) Medicine Name: Erandamooladi niruha basti, Reference: charaka samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 469(ml), Frequency: od, Duration: 6 Days
3
Comparator Arm
Procedure
-
bastikarma, बस्तिकर्म
(Procedure Reference: charaka samhita, Procedure details: Poorvakarma: Patient will be advised to take treatment just after the food intake, after ensuring the passing of motion, urine & flatus. Patient will be made to lie down in supine position on the Droni. Sthanika Abhyanga will be done followed by Sthanika Patrapinda Sweda over lowerback, thighs and buttocks. Patient will be asked to lie in the left lateral position by keeping left hand under the head with left leg extended and right leg flexed at the hip and knee joint towards chest .
Pradhanakarma : With gloved hands therapist will smear oil ,to the tip of the catheter and anal orifice of the subject for lubrication with help of the cotton swab. Therapist will hold the syringe in left hand and with the right hand the clamped artery forceps will be removed. Then the catheter will be gently introduced into the anal canal in the direction of the spine for about 4 - 6 cms. Now without shaking or trembling and with uniform pressure Anuvasana Basti medicine will be administered with an unifom force and after that slowly rubber catheter will be removed out.
Paschatkarma : Lower back of the patient will be tapped ,after which the patient will be asked to lie in supine position with foot end elevation, abdomen will be massaged in anticlockwise direction . Instructions will be given to pass the bowel after getting the Vega. ) (1) Medicine Name: Sahacharadi taila, Reference: Ashtanga Hridaya, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 10 Days
4
Intervention Arm
Procedure
-
bastikarma, बस्तिकर्म
(Procedure Reference: charaka samhita, Procedure details: Poorvakarma: Niruha basti medicine is filled in enema can & kept ready. Patient will be advised to be on empty stomach, after ensuring the passing of motion, urine and flatus, patient will be made to lie down in supine position on the table. Sthanika Abhyanga will be performed followed by Sthanika Swedana done over lower abdomen, back, thighs and buttocks of the subject
Pradhankarma : With gloved hands therapist will smear oil ,to the tip of the catheter and anal orifice of the patient for lubrication with help of the cotton swab. Therapist will hold the enema can in the left hand and with the right hand catheter will be clamped artery forcep to prevent leakage. Then the catheter will be gently introduced into the anal canal in the direction of the spine for about 4 - 6 cms. Now Without shaking or trembling and with uniform pressure Niruha Basti will be administered by elevating the enema can and releasing medicine by releasing the clamp. Before the enema can becomes completely empty artery forceps will be once again clamped and the catheter will be withdrawn.
Paschatkarma : Gentle tapping over the buttocks will be done. Then patient will be asked to lie in supine position and rub his palms briskly against each other. At the same time the therapist will rub the soles vigorously followed by foot end elevation. Instructions will be given to pass the bowel after getting the Vega, followed by warm water bath and advised light diet.) (1) Medicine Name: Shampakadi Asthapana basti, Reference: Sushrut samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 449(ml), Frequency: od, Duration: 6 Days
5
Intervention Arm
Procedure
-
svedanam, स्वेदनम्
(Procedure Reference: panchakarma textbook by B A Lohit, Procedure details: Poorvakarma : Herbal leaves will be cleaned & choped into small pieces. Round bottom wide mouthed vessel will be taken, grated coconut will be added in to it and fried till it turns to brown tinge. Add all the chopped leaves , Haridra Churna , Rasna Churna, Saindhava Lavana and 100 ml oil will be added to it and fried together. Fried leaves will be put on a piece of cotton cloth and tied them with a thick thread properly to make an ideal Pottali. Pottali should weigh approximately about 350 grams.
Pradhanakarma : The subject is made to lie down on Droni in supine position and relax . Sahacharadi Taila will be applied locally over the Katipradesha (lowerback), thighs and buttocks of the subject , then therapists massage the same areas by moving his palms in circular and linear fashion. The prepared Pottali is taken and heated in a vessel containing little amount of oil. When Pottali is properly heated , it will be taken out from vessel and temperature will be confirmed by touching it on the dorsum of the hand. Then its is applied to the subjects body by tapping the Pottali with continuous movement of the hand. In This way by maintaining the constant temperature of Pottali the procedure of Patrapinda Sweda will be continued for 20 minutes.
Paschatkarma: The subject will be advised to rest for 10 minutes. The part treated with PatraPinda Sweda will be wiped with towel.) (1) Medicine Name: Nirgundi, eranda , arka, chincha, dhatura, Reference: panchakarma textbook by B A Lohit, Route: Topical, Dosage Form: Not Applicable, Dose: 350(g), Frequency: od, Duration: 10 Days
6
Intervention Arm
Procedure
-
bastikarma, बस्तिकर्म
(Procedure Reference: charak samhita, Procedure details: Poorvakarma: Patient will be advised to take treatment just after the food intake, after ensuring the passing of motion, urine & flatus. Patient will be made to lie down in supine position on the Droni. Sthanika Abhyanga will be done followed by Sthanika Patrapinda Sweda over lowerback, thighs and buttocks. Patient will be asked to lie in the left lateral position by keeping left hand under the head with left leg extended and right leg flexed at the hip and knee joint towards chest .
Pradhanakarma : With gloved hands therapist will smear oil ,to the tip of the catheter and anal orifice of the subject for lubrication with help of the cotton swab. Therapist will hold the syringe in left hand and with the right hand the clamped artery forceps will be removed. Then the catheter will be gently introduced into the anal canal in the direction of the spine for about 4 - 6 cms. Now without shaking or trembling and with uniform pressure Anuvasana Basti medicine will be administered with an unifom force and after that slowly rubber catheter will be removed out.
Paschatkarma : Lower back of the patient will be tapped ,after which the patient will be asked to lie in supine position with foot end elevation, abdomen will be massaged in anticlockwise direction . Instructions will be given to pass the bowel after getting the Vega.) (1) Medicine Name: Sahacharadi tails, Reference: Ashtanga Hrudaya, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 10 Days
Inclusion Criteria
Age From
21.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
Subjects fulfilling the diagnostic criteria of Gridhrasi ( Sciatica ).
Subjects between the age group of 21 - 60 years irrespective of gender, religion, occupation and socioeconomic status.
Subjects fit for Basti Karma and Patrapinda Sweda.
Subjects presenting with clinical signs and symptoms of Gridhrasi.
Subjects who are willing to give a written consent for the treatment.
ExclusionCriteria
Details
Subjects below 21 years and above 60 years of age.
Subjects unfit for Basti Karma and Patrapinda Sweda.
Systemic diseases which interfere with the course of treatment will be excluded.
Subjects with spinal deformity, severe traumatic condition like compressive fractures, Quada equina compression, tuberculosis of the spine or any infective and inflammatory diseases of spine , benign or malignant tumors of spine ,Post-surgical conditions of lumbar spine,AVN of head of femur.
Pregnant and lactating women.
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
Alternation
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
PRIMARY OUTCOME:
Significant reduction in symptoms of Gridhrasi (Sciatica) as assessed based on subjective and objective parameters.
0th, 10th, 30th day
Secondary Outcome
Outcome
TimePoints
SECONDARY OUTCOME:
Generation of data on adverse effect of drug or event if any.
Generation of in-depth analysed data on the different aspect of the disease.
To assess the effect of therapy on the quality of life based on Oswestry Disability Index scale.
Trial period – 10 days
Initial assessment – 0th day
Assessment on - 10th day
Follow up - 30th day
Total study duration - 30 day.
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)
23/08/2025
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 - NO
Brief Summary
Gridhrasi is one among the Vata Vyadhi described in Ayurveda, in which Shoola and Chestahani are the main symptoms,which makes a person to compromise his/her physical, psychological, and social efficiencies. Gridhrasi is also one among Vataja Nanatamja Vyadhi mentioned by Acharya Charaka. In Gridhrasi, there is a intense shooting type of pain radiating in sequential order from Sphik, (gluteal region ), PrusthaBhaga of Kati (lumbo-sacral region), Uru, Janu, Jangha ,and Pada with Ruk ,Toda and Sthamba.
Today’s lifestyle and nature of work have a pattern of increasing tension on health, because of activities like over exertion, sedentary occupation, heavy weight lifting, jerky movements during travelling, use of high heeled footwares, long standing, there is increase in disorders related to the locomotor system like Gridhrasi which has affected the day to day activities of people there by creating disturbances in their personal, professional and social life .
Vatavyadhi is one among Mahagada explained in Ayurveda, prognosis is poor in Vatavyadhi because of development of complications and Gridhrasi is one among them .
Gridhrasi can be co-related with Sciatica in contemporary science because of similarity in presenting complaints. Sciatica is defined as pain in the Sciatic nerve or its component nerve roots.Sciatica is one of the most significant health problems in current-day practice. It also contributes to social life as well as economic crises in the form of deterioration in work productivity. Sciatica is the prime factor for disability & ranks 6th for the overall burden on the world population. The lifetime incidence of Sciatica is reported to be between 10% to 40% and an annual incidence of 1% to 5%. The majority of incidence occurs in the 4th – 5th decade of the working population.The prevalence of Sciatica varies considerably ranging from 1.6% in the general population to 43% in the working population.
In contemporary medical science, treatment of Sciatica includes analgesics, anti-inflammatory drugs, steroid injections and physiotherapy.
Ayurveda classics explain the treatment for Vatavyadhi in detail, in which Snehana, Swedana & Mridushodhanaare the prime line of treatment for vitiated Vata dosha. One of the prime line of treatment of Gridhrasi is Bastikarma.Basti is considered as Ardha Chikitsa by Charaka and Vagbhata because of its high efficiency in treating all the diseases, it holds a special place in the treatment of Vatavyadhi ,also Basti is the line of treatment for Vata dosha. The proper execution of these treatment principles will help in relieving the symptoms of the Gridhrasi.
Considering the above factors, an attempt has been made to clinically evaluate the combined efficacy of Shampakadi Asthapana Basti and Patrapinda Sweda with ErandamooladiNiruha Basti and Patrapinda Sweda in the management of Gridhrasi .