| CTRI Number |
CTRI/2024/11/076111 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Shodhan Basti over Isabgol husk in Mala Avruta pakwasyagata Vata w.s.r to Functional Constipation |
|
Scientific Title of Study
|
An Open Label Randomized Comparative Clinical Trial To Evaluate The Efficacy Of Shodhan Basti Over Isabgol Husk In The Management Of Mala Avruta Pakvasyagata Vata (Chronic Functional Constipation) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balyogeshwar Sharma |
| Designation |
PhD Scholar Panchakarma Department |
| Affiliation |
Shri Krishna AYUSH University |
| Address |
Panchakarma Department OPD Divison Room No.14 Baba Khetanath Govt. Ayurveda College and Hospital Patikara Narnaul
Kurukshetra
HARYANA
123001
India |
| Phone |
7411377820 |
| Fax |
|
| Email |
vasisth.yogi3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Mehta |
| Designation |
Professor |
| Affiliation |
Shri Krishna AYUSH University |
| Address |
Department of Panchakarma,
Shri Krishna AYUSH University Umri Road Sector-8 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8950375285 |
| Fax |
|
| Email |
drashishhmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Balyogeshwar sharma |
| Designation |
PhD Scholar Panchakarma Department |
| Affiliation |
Shri Krishna AYUSH University |
| Address |
Panchakarma Department OPD Divison Room No.14 Baba Khetanath Govt. Ayurvedic College & Hospital Patikara Narnaul
Kurukshetra
HARYANA
1234001
India |
| Phone |
07411377820 |
| Fax |
|
| Email |
vasisth.yogi3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baba Khetanath Govt. Ayurvedic College & Hospital, Patikara, Narnaul Haryana 123001 India |
|
|
Primary Sponsor
|
| Name |
Balyogeshwar Sharma |
| Address |
328-R Model Town Rewari |
| 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 Balyogeshwar sharma |
Baba Khetanath Govt. Ayurvedic college |
vinayak ayurveda hospital, 328-r, model town, rewa
near urja park
Rewari
HARYANA |
07411377820
vasisth.yogi3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, SKAU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: PAKVASAYAGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Dalhan Tika on Su.Ch. 4/5, Procedure details: Shodhana basti in the Kaala basti pattern for a period of fifteen days.
Shodhan Basti -960ml
Anuvasan Basti-120ml)
| | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Isabgol Husk, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients meeting the “Rome III diagnostic criteria for functional constipationâ€
2.Patients with a stool form score ranging from 1 to 3 on the “Bristol Stool Form Scaleâ€
3.Patient with the symptom of mala-avruta vata
|
|
| ExclusionCriteria |
| Details |
Patients on chronic laxative medications |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shodhana Basti will show improvement in the symptoms of Mala Avruta vata assessed by “Bristol stool form scale†and Pureeshavruta vata assessment scale.
|
1.5 yrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shodhana Basti will be more effective in the management of Mala Avruta vata than Isabgol |
1.5 yrs |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
01/01/2025 |
| 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
|
Constipation is a
common gastrointestinal condition characterised by unsatisfactory defaecation
as a result of infrequent stools, difficult stool passage, or both. The term functional constipation
(FC) has been proposed and defined by the Rome Foundation to help standardise
the diagnosis of chronic constipation in the absence of physiological
abnormality.Contemporary laxatives, which are generally used in
Constipation, become habitual after some duration and gives only symptomatic
relief. Moreover, these medicines never alter pathogenesis of disease.The formulation used in this study i.e., Shodhana
Basti is indicated for the treatment of Mala avruta Pakwashyagata vata. With
this idea present study is planned to evaluate the effect of Shodhana Basti
in Mala avruta Pakwasyagata vata.The study will be An
Open Label Randomized Comparative clinical trial.In Control Group patients
will be advised to mix 5gm of Isabgol husk ( Plantago ovata )in 200 ml of lukewarm water, stir well, and consume
immediately twice a day for 15 days. In Trial
group participants will get Shodhana basti in the Kaala basti
pattern for a period of 15 days. After that follow-up will be conducted on 30th
,45th and 60th day.The data will be
statistically analysed by and will be presented in the form of dissertation. |