A randomized, comparative, open clinical trial for evaluating the efficacy of PP/JLN/107/09-10 Syrup in the management of Functional Constipation

Dr. Padmanabha Rugved; Pankaj Kumar Gupta; JLN Sastry; M. Ramadas; Rajiva Kumar Rai

doi:10.21760/jaims.v5i06.1118

Dr. Padmanabha Rugved Principal Scientist, Dabur India Limited, New Delhi, INDIA.
Pankaj Kumar Gupta DRDC, Dabur India Limited,
JLN Sastry Former Head,Healthcare R&D, Dabur India Limited, INDIA.
M. Ramadas Principal, Dhanwanthari Ayurvedic College & Hospital, Chandigarh, INDIA.
Rajiva Kumar Rai DRDC, Dabur India Limited,

DOI: https://doi.org/10.21760/jaims.v5i06.1118

Keywords: Functional Constipation, PP/JLN/107/09-10, Isabgol, Clinical Study, Rome II Criteria

Abstract

Context: Functional constipation which has no underlying organic causes is difficult to be allopathic treatment for long term due to its side effects and undeniable effect, thus a natural balanced and compatible formulation needs to be validated. Objectives: Current study aimed to assess a poly-herbal formulation in management of functional constipation. Material and Methods: This study was 28 days, two armed, randomized, open labeled, prospective clinical study. 60 clinically confirmed cases of functional constipation patients randomized to receive orally either 2 teaspoonful of PP/JLN/107/09-10 Syrup or 1 teaspoonful of 5- 6 gm of Isabgol powder. Results were analyzed as per Rome II criteria and other associated symptoms like headache, acidity, belching, barborgysmy, flatulence and abdominal distension or bloating which are recorded on VAS score. Results: PP/JLN/107/09-10 scored over Isabgol on four out of six parameters of Rome II Criteria viz., frequency of bowel movement, straining at defecation, lumpy I hardstool formation, feeling of incomplete evacuation, feeling of ano-rectal blockage and manual maneuvers (p < 0.001). Trial drugs showed comparable effects (p > 0.05) in reducing the mean scores of associated symptoms like headache, acidity, belching, borgorgysmy, flatulence and abdominal distension. However, trial drug was found to perform statistically significant result in more number of parameters in comparison to Isabgol. Conclusion: PP/JLN/107/09-10 was found to be effective and safe in reliving functional constipation.

Downloads

Download data is not yet available.

References

Aswal B.S. et al.; Screening of Indian plants for biological activity. Part XI. Ind. J. of Exp. Biol22, 487. 1984.

Bhattacharya I. C.; Pharmacological study of Indian Jalap. Ind. J. Pharm. 23: 186, 1961

Chen G et al, lsoliquiritigenin, a flavonoidfrom licorice, plays a dual role in regulating gastrointestinal motility in vitro and in vivo. PhytotherRes. 2009 Apr; 23(4):498- 506.

Khare AK et al.; A preliminary study of antiinflammatory activity of Ipomoea turpethum (Nisoth).Indian Drugs 19:224, 1982.

Pandey T.N.; Vibandhroga mein Trivrita evam Yogasana chikitsa ka tulanatmaka adhyayan. M.D.Thesis, P. G. Dept. of Kaya Chikitsa, Govt. Ayu. College, Raipur. 1987.

Shah C.S. et al.; 'Sugars and coumarins in black turpeth (Ipomoea turpethum). Ind. J. Pharm 34:126, 1972.

Tripathi O.D.; A study if virechan with special reference to cathartic effect of Trivrita. M.D. Thesis, P.G.Dept. of Kaya Chikitsa, lnst. Of P.G. Educ. & Res. In Ayurveda, Calcutta, 1989.

Lembo A and Camilleri (2003), Current Concepts Chronic Constipation. NEJM; 349(14): 1360-1368.

Kim, T. et al. (2004), Effect of ear mushroom (Auricularia) on Functional Constipation. Kor J Gastro; 44:34-41.

Bassetti, G. et. al. (2004), An extended assessment of bowel habits in a general population. 11. World J Gastroenterol; 10(5):713-716.

Sandler RS and pressman DA (1987) Bowel habits in young adults not seeking health care. Dig Dis Sci; 32(8):841-5.

Anand AC et. al. (1998) A search for unhappy abdomen: prevalence of irritable bowel syndrome in general population. Medical Journal Armed Forces India; 54(2): 123-7.

Koch A et. al. (1997) Symptoms in chronic constipation. Dis Colon Rectum; 40(8):902-6.

Burnett CA et. al. (2004). Nurse Management of intractable functional constipation: a randomised control trial. Arch Dis Child; 89:717-722.

NakajiS et. al. (2004). A population based study on defecatory conditions in Japanese subjects: methods for self-evaluation. Tohoku J Exp Med; 203, 97-104.

Salwan WA, Basson MD (2004). Elect of four day psyllium supplementation on bowel preparation for colonoscopy: a prospective double blind randomized trial. BMC Gatroenterology;4:2.

Chunekar K.C., Pandey G.S., (1986): Bhavprakash Nighantu, Chaukhambha Bharati Academy.