| CTRI Number |
CTRI/2025/04/084034 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy and safety of kosthasuddhikriya( an Yogic technique) versus Prucalopride for treatment of patients with functional constipation. |
|
Scientific Title of Study
|
Efficacy and safety of kosthasuddhikriya versus Prucalopride in patients with functional constipation: a pilot non-inferiority randomized controlled trial. |
| Trial Acronym |
YOGIC Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manas Kumar Panigrahi |
| Designation |
Additional Professor, Gastroenterology |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department Of Gastroenterology, AIIMS , Bhubaneswar, Sijua, Patrapada
Khordha
ORISSA
751019
India |
| Phone |
9861278332 |
| Fax |
|
| Email |
manaskumarpanigrahi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhabrata Biswal |
| Designation |
DM -SR Academic, Gastroenterology |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department Of Gastroenterology, AIIMS , Bhubaneswar, Sijua, Patrapada
Flat 304, Ekdanta Galaxy, Kalyani nagar , Patrapada, Bhubaneswar, 751019
Khordha
ORISSA
751019
India |
| Phone |
9556565181 |
| Fax |
|
| Email |
subhabratabiswal001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manas Kumar Panigrahi |
| Designation |
Additional Professor, Gastroenterology |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department Of Gastroenterology, AIIMS , Bhubaneswar, Sijua, Patrapada
Khordha
ORISSA
751019
India |
| Phone |
9861278332 |
| Fax |
|
| Email |
manaskumarpanigrahi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Gastroenterology , AIIMS BBSR, Odisha |
|
|
Primary Sponsor
|
| Name |
Dr Manas kumar panigrahi |
| Address |
Department of gastroenterology, AIIMS BBSR,SIJUA,PATRAPDA |
| 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 |
| SUBHABRATA BISWAL |
AIIMS Bhubaneswar |
Room No 223, 2nd Floor, Gastroenterology OPD, Department of Gastroenterology
Khordha
ORISSA |
9556565181
subhabratabiswal001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS BBSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K590||Constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KOSTHASUDDHIKRIYA(KSK) |
KSK is a sequential of yoga asanas comprising of Tadasana(Palm tree pose), tiryaka tadaasana(swinging palm tree pose), katichakarasna(satnding spinal twist pose), Tiryakabhujangasana(twisting cobra pose), udrakarshanasana(abdominal twist), Mandukasana(Frog pose) , each asana will be performed 8 times followed by drinking 400 ml of luke warm water in malasana(Garland pose) pose. Total 3 cycles will be done . |
| Comparator Agent |
PRUCALOPRIDE |
Tablet PRUCALOPRIDE 2mg Per Oral to be taken once a day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male and non-pregnant female subjects (18-65 years of age) with clinical diagnosis of functional constipation (As per ROME IV criteria) with BMI of 18-35 Kg/m2 will be included in the trial, Willing to comply with protocol requirements and sign a statement of informed consent, Willing to stop any laxatives used before the Pretreatment period in favor of the protocol-defined Rescue Medicine (bisacodyl tablets or suppositories),Agree to abstain from making any fresh, significant lifestyle adjustments that might impact symptoms (such as altering their workout regimen or nutrition) between the time the ICF was signed and the final trial visit. |
|
| ExclusionCriteria |
| Details |
age less than 18 and more than 65 with significant comorbidity like uncontrolled diabetes, uncontrolled hypertension secondary Constipation due other disease or drug, IBD, past GI surgery, Pregnant and lactating mothers, People with HCV/HBV/HIV seropositive, not willing to give consent, not able to perform KSK asana due to muskuloskeletal disoredes will be excluded |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine and compare the efficacy of Kosthasuddhikriya (KSK) with Prucalopride for treatment of Functional Constipation in terms of Complete spontaneous bowel movement per week (CSBM) and Bristol stool form scale (BSFS).
|
At baseline, 4 WEEKS, 8 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of KSK for treatment of patients with Functional constipation in terms of various GI symptom scores Change in average weekly Abdominal pain/bloating/straining/sense of incomplete evacuation scores. |
At 2,4,6,8 week of intervention |
| To evaluate the safety and acceptability of KSK as a treatment of patients with Functional constipation. |
At 8 week |
| To determine the proportion of patients requiring rescue treatment in both study arms. |
At 8 week of intervention |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/04/2025 |
| 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 Yet Recruiting |
| 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
|
YOGIC(Yoga In Constipation) trial is a Randomized controlled parallel group single blinded study design to determine the safety and efficacy of Kosthasuddhikriya (KSK) as compared to Prucalopride for the treatment of functional constipation. KSK is a yogic technique designed and created combining sequential set of specific Yoga asanas like: Tadasana, tiryaka tadasana, kati chakrasana, tiryak bhujangasana, udarakarshanasana, mandukasana and drinking 400 ml of luke warm water in malasana. KSK is a modified form of Sankshaprakhalana (SP) which is an yogic technique used for bowel cleansing in ancient Indian science. Recently few studies on role of SP in Bowel preparation and cleansing prior colonoscopy published in Indian journal of gastroenterology. However, no study till date has explored therapeutic role of yoga in constipation as for best of our knowledge. In this trial patient diagnosed to have functional constipation as per rome IV crteria will undergo screening and baseline assessment followed by 1:1 Randomization will be done into two study arms using a sealed envelope concealment method (computer generated) investigator will be blinded during study allocation. After randomization each participant will be provided a bowel health dairy for recording of their parameters, symptoms and yoga teaching will be done by YOGA instructors and recorded KSK Yoga videos will be provided for subsequent use to Yoga arm participants and Prucalopride 2 mg Tablet will be provided to Prucalopride arm. Biscodyl 5 mg tablet will be provided to each group as a rescue therapy. Efficacy Outcome assessment will be in terms of Complete spontaneous bowel movement score and Change in bristol stool form scale(BSFS) Score. Secondary out comes will be assessed in terms of various symptom score(meausred in likert scale) . Acceptability and safety will be assessed by a pre validated questionnaire. |