| CTRI Number |
CTRI/2025/10/096639 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare how effective Piccha Basti (a special Ayurvedic enema) and Sheetala Dhara (a cooling therapy) are in helping people with ulcerative colitis (a type of long-term inflammation in the large intestine) |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Effect Of Piccha Basti And Piccha Basti With Sheetala Dhara In Management Of Ulcerative Colitis |
| 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 Nainika J Chouta |
| Designation |
Pg scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Research Centre,Kuthpady Udupi |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Research Centre,Kuthpady Udupi
Department of Panchakarma
Udupi
KARNATAKA
574119
India |
| Phone |
9008973009 |
| Fax |
|
| Email |
nainikachouta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niranjan Rao |
| Designation |
Professor And Head of Panchakarma Department |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Research Centre,Kuthpady Udupi |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Research Centre,Kuthpady Udupi
Department of Panchakarma
Udupi
KARNATAKA
574118
India |
| Phone |
9448835203 |
| Fax |
|
| Email |
rao.drniranjan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nainika J Chouta |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Research Centre,Kuthpady Udupi |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Research Centre,Kuthpady Udupi
Department of Panchakarma
Udupi
KARNATAKA
574118
India |
| Phone |
9008973009 |
| Fax |
|
| Email |
nainikachouta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Nainika J Chouta
PG Scholar
Department of PG Studies in Panchakarma
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Research Centre,Kuthpady Udupi |
|
|
Primary Sponsor
|
| Name |
Dr Nainika J Chouta |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Research Centre,Kuthpady Udupi |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Research Centre |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Research Centre,Kuthpady Udupi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nainika J Chouta |
Sri Dharmasthala Manjunatheshwara Hospital Of Ayurveda |
Sri Dharmasthala Manjunatheshwara hospital Of Ayurveda
Department of Panchakarma Kuthpady,UDUPI
Udupi
KARNATAKA |
9008973009
nainikachouta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College Of Ayurveda Udupi Institutinal ethical clearance committee-humans |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K519||Ulcerative colitis, unspecified. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | picCA/picCila-bastiH, पिच्छा/पिच्छिल-बस्तिः | (Procedure Reference: Charaka Chikitsa 19 64-66, Procedure details: route of administration - rectal
duration of therapy - 8 days
POORVAKARMA
PREPARATION OF THE MEDICINE
Ingredients
Kashaya drugs shalmali twak, go dughda
Kalka drugs yasti madhu choorna
Preparation of ksheera paka First 250gm of kashaya drugs is taken. To this 8000 ml
water &2000ml of godugdha is added & boiled till it is reduced to 250 ml.
Preparation of basti
1. Madhu 80ml
2. Saindhava lavana 5 gm
3. Jathyadi taila ,Yashtimadhu Taila 60 ,60 ml= 120
4. Yashtimadhu choorna kalka 40 gm
5. Kwatha 250ml
PREPARATION OF THE PATIENT
Patients will be advised to be on empty stomach for Piccha Basti & consume food
before the administration of Anuvasana Basti.
Sthanika abhyanga with Murchita tilataila & Sthanika swedana by Nadi sweda to
abdomen & buttock will be done.
PRADHANA KARMA
Patient will be asked to lie in the left lateral position by keeping left leg straight and
right leg flexed at the knee & hip joint.
Dose- 480ml
Frequency- Six basti will be administered on the 2nd 3rd 4th 5th 6th & 7th day in the morning on an empty stomach.
Eight Anuvasana basti with murchita tila taila 60ml will be administered on 1st 2nd 3rd 4th 5th 6th 7th 8th day in the afternoon, immediately after food
PASCHAT KARMA
Patient will be advised to turn to supine position until he gets urges.
Patient will be advised to pass the bowel after getting the urge.
Patient will be advised to avoid ashta mahadoshakara bhavas.
Parihara kala of 14 days
)
| | 2 | Comparator Arm | Procedure | - | sekaH, सेकः | (Procedure Reference: Dhara kalpa, Procedure details: route - topical
duration - 30mins
frequency - 7 days
dose - 2 litre
POORVA KARMA
PREPARATION OF THE MEDICINE
Ingredients
1.Arjuna leaves
Preparation of sheethala dhara dravya freshly prepared arjuna leaves have to be
thoroughly washed & then soaked & macerated in fresh water for 30mins.later it is
filtered & used for the treatment.
PRADHANA KARMA
Patient is asked to lie in supine position & then gauze is tied around his forehead just
above the eyebrow
In a continuous & constant speed, the dhara has to be poured onto the forehead of the patient from side to side for 30 mins.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of Ulcerative Colitis
Patients fit for Basti. |
|
| ExclusionCriteria |
| Details |
Patients who are pregnant, lactating.
Any other systemic illness interfering with the treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the therapeutic efficacy of Piccha Basti alone and in combination with Sheetala Dhara in the management of Ulcerative Colitis, in terms of improvement in clinical symptoms, reduction in disease severity. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Bowel frequency
Abdominal pain
Blood in stool
Hb percentage
Samyak Niruda Lakshana
|
21 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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/11/2025 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Ulcerative Colitis is a Chronic Idiopathic Irritable Bowel Disease characterised by a superficial mucosal inflammation extending in variable degrees from the rectum to the more proximal colon.Symptoms of Ulcerative Colitis include bloody stools, rectal urgency with loose consistency, tensemus and varying degrees of abdominal pain .the goal of treatment in Ulcerative Colitis focus on improving quality of life and achieving steroid free remission. |