ICB 014 (Woodfordia fructicosa) Capsules
Indication: Gastro protective/ Anti Ulcer

Medical/Pharma/Health care

In an endeavour to make available high quality and innovative products in India, CSIR-IIIM Jammu initiated to conduct the Phase I Clinical trial titled "A Phase- I, Dose escalation study to evaluate safety, tolerability and Pharmacokinetic of ICB014 A002, Herbal Capsule in healthy adult volunteers" in collaboration with one of the Indian CRO company at Apollo hospitals, Ahmadabad, Gujarat with registered Clinical trial Registry of India (CTRI) bearing number CTRI/2018/01/011259 dated: 10/01/2018. In addition to the above, Apollo Ethics committee approved the proposed study to conduct the same on conditionally. As per current status of the study, it is informed that, Phase- I Clinical trial studies (Dose Escalation Study to evaluate safety, tolerability and pharmacokinetic of ICB-014-A002 capsule) was successfully completed. The present
invention technology comprises an effective amount of an extract/ lyophilized (Hydro alcoholic) extract along with one or more pharmaceutical acceptable additives/carriers.
In this review, attempts have been made to identify some medicinal plants which may be used in ayurveda as well as modern science for the treatment or prevention of peptic ulcer. With this background data, IIIM, Jammu has developed standardized drug product i.e., ICB 014-A002 Capsule. The manufacturing procedure has been scaled up (in cGMP facility) and all the manufacturing process has been optimized. Analytical
method for drug substance: and Drug product has been developed and validated at QC/QA section, IIIM Jammu. Drug Product was found to be stable when stored at 40°C±2°C 75% ±5%RH for 6 months and 30°C±2°C 65% ±5%RH for 18 months in PVC bottle pack. This invention envisages the potential of an extract obtained from the flower of the plant to act as an effective therapy against peptic ulcer disease (Indication: Anti- Ulcer). IIIM Jammu, ICB014 A002, Herbal capsule formulation with trade mark/brand name under Trade Mark (TM) class 5, registered with Controller General of Patents Design & Trade marks, as "Ulcrine" and same was accepted & advertised by the said authority on 23/04/2018. 

• This scientific evidence based traditional knowledge for the treatment of gastric ulcer and Gastric protective agent.