| CTRI Number |
CTRI/2025/04/084822 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized Comparative Clinical Study of Two Different Enema Formulation in Ischemic Stroke. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to Evaluate The Efficacy of Balakulathyadi Kashaya Basti over Dashamoola Ksheera Basti In Pakshaghata with Special Reference to Ischemic Stroke. |
| 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 Seema Desai |
| Designation |
PG RESEARCH SCHOLAR |
| Affiliation |
Shri D.G.M Ayurvedic Medical College, Hospital PG AND Ph.D. Studies, Research Centre Gadag, Karnatak |
| Address |
Department of Panchakarma
OPD no 2
Shri D.G.M Ayurvedic Medical College, Hospital PG AND Ph.D. Studies, Research Centre Gadag, Karnatak
582103, India
Department of Panchakarma
OPD no 2
Shri D.G.M Ayurvedic Medical College, Hospital PG AND Ph.D. Studies, Research Centre Gadag, Karnatak, India, 582103
Gadag
KARNATAKA
582103
India |
| Phone |
9113533253 |
| Fax |
|
| Email |
seemadesai1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Desai |
| Designation |
PG RESEARCH SCHOLAR |
| Affiliation |
Shri D.G.M Ayurvedic Medical College, Hospital PG AND Ph.D. Studies, Research Centre Gadag, Karnatak |
| Address |
Department of Panchakarma
OPD no 2
Department of Panchakarma
OPD no 2
Shri D.G.M Ayurvedic Medical College, Hospital PG AND Ph.D. Studies, Research Centre Gadag, Karnatak
KARNATAKA
582103
India |
| Phone |
9113533253 |
| Fax |
|
| Email |
seemadesai1999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jairaj P Basarigidad |
| Designation |
Professor and HOD |
| Affiliation |
Shri D.G.M Ayurvedic Medical College, Hospital PG AND Ph.D. Studies, Research Centre Gadag, Karnatak |
| Address |
Department of Panchakarma
OPD no 2
Department of Panchakarma
OPD no 2
Shri D.G.M Ayurvedic Medical College, Hospital PG AND Ph.D. Studies, Research Centre Gadag, Karnatak
Gadag
KARNATAKA
582103
India |
| Phone |
9448516176 |
| Fax |
|
| Email |
jairajpb111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri D.G.M Ayurvedic Medical College, Hospital PG AND Ph.D. Studies, Research Centre Gadag, Karnatak, India 582103
|
|
|
Primary Sponsor
|
| Name |
Dr Seema Desai |
| Address |
Department of Panchakarma
OPD no 2
Shri D.G.M Ayurvedic Medical College, Hospital PG AND Ph.D. Studies, Research Centre Gadag, Karnatak, India 582103 |
| 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 Seema Desai |
Shri D.G.M Ayurvedic Medical College, Hospital PG AND Ph.D. Studies, Research Centre Gadag, Karnatak |
Department of Panchakarma
OPD no 2
Shri D.G.M Ayurvedic Medical College, Hospital PG AND Ph.D. Studies, Research Centre Gadag, Karnatak
582103
India
Gadag
KARNATAKA |
9113533253
seemadesai1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department of Panchakarma OPD no 2 Shri D.G.M Ayurvedic Medical College Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I679||Cerebrovascular disease, unspecified. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Sharangadhara samhita, Procedure details: METHOD OF ADMINISTRATION OF ANUVASANA BASTI
Gently the Basti Netra will be introduced into the rectum.
Introduce the medicine into the rectum by asking the patient to take the deep breath
and not shake his body.
Anuvasana Basti with Murchita Tila Taila will be Administered on 1st, 3rd, 5th, 7th and
8th day in Ardhrapani(Just after meal).
The Basti Netra will be Released carefully when a little quantity of Sneha is remained
inside the enema syringe.
METHOD OF ADMINISTRATION OF NIRUHA BASTI
The Basti Netra will be introduced slowly in the direction of the vertebral column up
to 1/4th part of the Netra.
Then hold the Basti Putaka in the left hand and keep the right hand on the Basti
Netra. After that administer the Basti Dravya uniformly, neither too fast nor too slow
without shaking the hand and instruct the patient to breath in deeply.
)
(1) Medicine Name: Bala kulathadi kashaya, Reference: Sahasrayoga, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 8 Days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Sharangadhara samhita, Procedure details: METHOD OF ADMINISTRATION OF ANUVASANA BASTI
Gently the Basti Netra will be introduced into the rectum. Introduce the medicine into the rectum by asking the patient to take the deep breath and not shake his body. Anuvasana Basti with Murchita Tila Taila will be Administered on 1st, 3rd, 5th, 7th and 8th day in Ardhrapani(Just after meal). The Basti Netra will be Released carefully when a little quantity of Sneha is remained inside the enema syringe.
METHOD OF ADMINISTRATION OF NIRUHA BASTI
The Basti Netra will be introduced slowly in the direction of the vertebral column up to 1/4th part of the Netra. Then hold the Basti Putaka in the left hand and keep the right hand on the Basti Netra. After that administer the Basti Dravya uniformly, neither too fast nor too slow without shaking the hand and instruct the patient to breath in deeply.)
(1) Medicine Name: Dashmoola Kshreera basti, Reference: Susruta samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Loss of Function of Half side of the body with or without Speech Involvement.
2. Pain in either side of the body.
3. Numbness or Weakness of either side of the body.
4. Subjects of either Gender is included.
5. Subjects of age groups between 30 – 70 years are included.
6. Subjects with Ischemic stroke without any severe complications.
7. Subjects fit for Basti Karma. |
|
| ExclusionCriteria |
| Details |
1. Subjects who are disoriented and unconscious.
2. Subjects with Diabetes who are on medication,
3. Blood Pressure equal or above 180/120mm Hg.
4. Pakshaghata complicated with, H/o Intra cranial infections like, meningitis, encephalitis
etc.
5. Post traumatic Hemiplegia.
6. Haemorrhagic stroke.
7. Cerebral tumours.
8. Congenital defects such as Arteriovenous malformation, Aneurysm, Diffuse sclerosis,
Cerebral agenesis & other major Cerebrovascular anomalies.
9. Subjects suffering with Chronic Kidney Diseases, Acute Kidney Diseases, Congestive
Cardiac Failure & Ischemic Heart Disease.
10. Subjects with Acute Ischemic Stroke. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in cardinal feature of Pakshaghata (Cheshta Nivrutti
of Vama and Dakshina parshwa,Vaksanga, Ardha kaya Karmahani,Suptata in Hasta
and Pada) |
After Treatment
8 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of Improvement through stroke scale of national
institute of health,Institute of neurological disorders and stroke (NIH, NINDS) and
Modified Rankins Disability Scale. |
After follow up
24 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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="6"
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
|
Pakshaghata is one among the “Vatavyadhi” & is Duschikitsa, Vata is the most powerful Dosha in our body as it responsible for both Maintenance & Vitiation of other Dosha, Dhatu & Mala. The Diseases caused by Vata in its vitiated condition is called “Vatavyadhi”. There are 80 Nanatmaja Vatavyadhi. Pakshaghata is one among the Vataja Nanatmaja Vyadhi, there will be impairment in Karmendriyas, Gynanendriyas& Manas. Even though Pakshaghata is mentioned in Nanatmaja Vatavikaras of Charaka, it is not only a Shuddha vataja condition there is a samsarga of Pitta and Kapha dosha as mentioned by Sushruta and Madhavakara.The Lakshanas are Cheshta Nivrutti of Vama or Dakshina Parshwa, Ardhakaya Karmahani, Suptata in Hasta and Pada and Vaksthamba.Kaphanubandha, Pittanubandha, Dhatukshayajanya and Margavaranajanya are the types of Pakshaghata.Acharya Charaka highlighted that “BASTI VATA HARANAM SHRESTA" Basti is a treatment which is considered as “ARDHA CHIKITSA” for Vata Dosha, as it Controls the Vata,Prevent VimargaGamana , does the Sarva Dosha Shamana , Vatanulomana , SrotoShodhana & Shodhana of Doshas from “Pada to Mastishkya”.In the present study Balakulathyadi Kashaya Basti is Planned and Its Ingredients are Bala, Kulatha, Saireyaka, Pippalimoola, Punarnava, Masha, Godhuma, Jeevanti, Suradaru Jaya the properties like Vatahara, Tridosha Shamaka, and few are Anuvasanopaga which is expected to manage the Pakshaghata effectively. As Dashamoola Ksheera Basti is widely practiced in Pakshaghata. It’s Composition of drug influences Vatanulomana, Balya, Shothahara, Shoolahara, Amapachaka. It is also included in Shotahara Mahakashaya by Acharya Charak. On the basis of symptomatology of Pakshaghata is compared with Stroke. Stroke is the 2nd commonest cause of Death in India. According to “World Stroke Organization”, Stroke is a condition where the Blood supply to the Brain is Disrupted, Resulting in Oxygen Starvation of Brain, leading to Brain Damage and Loss of Function.Ischemic Stroke doesdisturbance of focal and global cerebral blood circulation with symptoms lasting 24hours or longer and leading to Death.When Stroke occurs in the main Income earners in the household, there may be enormous consequences for the welfare of the family. The estimated prevalence rate of stroke range is 84-262/100000 in rural and 334-424/100000 Urban, incidence rate 119-145/100000 based on recent population. About 87% of all 1st ever in life time stroke are ischemic, 13% due to primary intra cerebral haemorrhage. Many Subjects retain permanent disability, spasticity and rigidity, because it is very difficult to make complete cure in the management of Pakshaghata. To overcome such conditions an attempt is made to evaluate the efficacy of Balakulathyadi Basti Karma in Pakshaghata. |