Objectives: The primary objectives of this trial are to evaluate the efficacy of the Sivathai Chooranam to compared with Nilavarai Chooranam in the management of Functional Constipation. This study is to explore the best proven Siddha treatment for the Management of functional constipation. The secondary objectives are to evaluate the safety of the Sivathai Chooranam and Nilavarai Chooranam on Functional Constipation and evaluate the patient quality of life using the PAC-QOL (patient assessment of constipation quality of life questionnaire. Trial Design: An open Labelled, Double arm, Single Centre, Exploratory and comparative Randomized Controlled Trial. Participants: Patients who Clinically confirmed Functional Constipation at Siddha Clinical Research Unit, New Delhi – OPD , both sexes aged 18-65, willing and consenting to participate will be recruited into the study. Main Outcomes: Primary outcomes: (21 Days) 30 % increase of Participant’s Bowel movement will be expected after completion of study which will be measured by Bristol stool Formation Scale and Modified Longo Score Randomisation: Randomization will be done following Simple randomization method. The Participants will be assigned into 2 Groups and will be allocated in 1:1 Ratio in each group through randomization blocks in Microsoft Excel by a Statistician after the assessment of eligibility and Informed consent procedures. Blinding: The Study is an open labelled. Participants and Investigators will not be blinded. Trial Status: Protocol Number: SCRU Constipation Study 1, Version: 6.0 Protocol Date: 01.03.2021.The Trial started its recruitment on 27.02.2021.We anticipate study including data analysis will finish in Aug 2021 with in a period of 3 months. Trial Registration: This trial was registered with (Clinical Trial Registry of India) CTRI and the registration number is CTRI/2019/02/017831
Impact Factor
2022: 6.012
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