Study Protocol of an Open Label Randomized Comparative Clinical Trial to evaluate the efficacy of Shodhana Basti over Isabgol Husk in the management of Mala Avruta Pakvasyagata Vata (Chronic Functional Constipation)

Background: Constipation is used to describe symptoms that relate to difficulties in defecation. Contemporary laxatives, which are generally used in Constipation, become habitual after some duration and gives only symptomatic relief. So, it is a need of hour to search effective, safe & alternative formulations in Ayurveda, which can completely break the pathogenesis of Mala Avruta Vata. The formulation used in this study, i.e., Shodhana Basti is indicated for the treatment of Mala Avruta Pakwashyagata Vata. Objective: The Primary aim is to assess the effect of Shodhana Basti in the management of Mala Avruta Pakvashayagata Vata. The Secondary aim is to compare the efficacy of the Shodhana Basti and Isabgol Husk in Mala Avruta Pakvashayagata Vata. Methods: This ongoing study is an open-label randomized controlled interventional trial, with a sample size of 98 both in the trial and standard control group (including dropouts, 10%). Participants in the trial group will receive Shodhana Basti in the Kaala Basti pattern for a period of fifteen days. The participants in the control group will receive 5gm of Isabgol husk (Plantago ovata) in 200 ml of lukewarm water twice a day for 15days. Outcome Measures: The primary outcome will include the mean change in the symptoms of Mala Avruta Vata assessed by “Bristol stool form scale” and Pureeshavruta Vata assessment scale. The secondary outcomes will include the effectiveness of Shodhana Basti in the management of Mala Avruta Vata than Isabgol Husk. Ethics: Ethics approval was taken from the Institutional Ethics Committee following which recruitment will be commenced in January 2025. Clinical Trial Registration: CTRI/2024/10/075705 dated 23.10.2024