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| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 16
| Issue : 2 | Page : 106-111 |
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A randomized controlled trial to evaluate the laxative effect of prescribed diet compared with Triphala Churna in Vibandha with special reference to constipation
Pooja Saini, Sarvesh Kumar Agrawal
Department of Swasthavritta and Yoga, National Institute of Ayurveda, Jaipur, Rajasthan, India
| Date of Submission | 29-Sep-2020 |
| Date of Decision | 27-Jan-2022 |
| Date of Acceptance | 27-Jan-2022 |
| Date of Web Publication | 4-Jul-2022 |
Correspondence Address:
Pooja Saini
Department of Swasthavritta and Yoga, National Institute of Ayurveda, Jaipur, Rajasthan
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/joa.joa_163_20
Introduction: Constipation is a common gastrointestinal complaint in apparently healthy population as well as in patients with various predisposing disorders with approximately 12%–19% global prevalence. Constipation is defined as “delay or difficult defecation causing significant distress to the patient.” In Ayurveda, various clinical conditions such as Krurakoshtha, Apanavayudusti, Vishtabdhajirna, Grahani have symptom of constipation called Vibandha. The presently available laxative drugs are habit-forming and financial burden to the patients. Treatment of constipation cannot be continuing for a longer period; therefore, it is a better option to put the patient on proper diet having laxative action in the condition of constipation. The objective of this work is to prepare a dietary module for patient of constipation and to evaluate the laxative effect of that prescribed dietary module (Pathyahara) in constipation. Methods: This study was conducted in two groups. Group A (Control): 3–6g (½ Karsh) Triphala Churna was given orally at night after meal daily with lukewarm water. Group B (Trial): Prescribed Dietary Module was advised as a daily diet. Results: Very significant result was found in both groups on all assessment parameters except weekly frequency of bowel movements in which result was significant in group A and no significant difference was there in all assessment parameters except weekly frequency of bowel movements and colic pain where the effect was more in Group B. Conclusion: Triphala Churna and prescribed dietary module having laxative effect in constipation. The effect was statistically more in prescribed dietary group on two parameters.
Keywords: Apanvayudusti, Krurakostha, laxative, vibandha
How to cite this article:
Saini P, Agrawal SK. A randomized controlled trial to evaluate the laxative effect of prescribed diet compared with Triphala Churna in Vibandha with special reference to constipation. J Ayurveda 2022;16:106-11 |
How to cite this URL:
Saini P, Agrawal SK. A randomized controlled trial to evaluate the laxative effect of prescribed diet compared with Triphala Churna in Vibandha with special reference to constipation. J Ayurveda [serial online] 2022 [cited 2022 Aug 10];16:106-11. Available from: http://www.journayu.in/text.asp?2022/16/2/106/349762 |
| Introduction | |  |
Constipation is a common gastrointestinal complaint in apparently healthy population as well as in patients with various predisposing disorders with approximately 12%–19% global prevalence.[1] The high prevalence rate, frequent medication, and adverse effect on the quality of life and the health state make constipation a major public health issue.[2],[3] Constipation is defined as “delay or difficult defecation causing significant distress to the patient. It is characterized by infrequent bowel evacuation, hard small feces with painful defection.”[4] In Ayurveda, various clinical conditions such as Krurakostha, Apanavayudushti, Vihstabdhajirna, Grahani have symptoms[5] of Vibandha. In general, the patients of Vibandha have a tendency for the Krura Koshtha and Vata is responsible for this type of Koshtha. Pakvashaya the main seat of Vibandha is the area of Apana Vata.
Treatment and getting cure for disease depend on the time taken for Nidana Parivarjan and Samprapti Vighatana.[6] Ayurveda mentions various treatment methods to obtain normalcy of Doshas to cure illness. The best to prevent reoccurrence of disease is to follow Pathyahara during and after the treatment. In mild diseases or initial stage of disease, only use of Pathya Ahara and Nidana Parivarjana may give complete cure for life time. In the patients of constipation, there is a requirement of Pathya Ahara which shows effect on Pureeshavaha Srotasa, easily palatable and plays the role in Samprapti Vighatana efficiently.
Many drugs are used to relieve constipation in Ayurveda as well as allopathic system of medicine such as Triphala Churna,[7] Haritki Churna,[8] Isabagol, milk of magnesia and glycerin suppositories. The anti-constipating drugs presently available are habit-forming therefore they are addition burden. It is a better option to put the patient on proper diet having laxative action in constipation rather than continuing treatment for lifelong.
Objectives
- To prepare dietary module for patient of constipation
- To evaluate the laxative effect of prescribed diet (Pathyahara) in constipation.
| Materials and Methods | | |
This whole work has been divided into two parts, literary study and clinical study.
Literary study
Various Samhita such as Charaka, Sushruta, Ashtanga Hridaya, and Bhava Prakasha Nighantu has been reviewed for literary study. The information was also collected from contemporary science including research papers regarding dietary effects on constipation. A dietary module for constipation was prepared on the basis of this review.[9],[10],[11],[12] This Module contains contemporary food (dietary) items along with the diet mentioned in the classical literature. Ahara Dravyas in dietary module as pathya (to be frequently used) were taken having Amla, Madhura, Ushna, Vibandhahara, Vatahara, Snigdha, Sara, and Deepana properties (Green colored in printed module). Apathya (Contraindicated diet) in Vibandha were taken Katu, Tikta, and Kashaya Rasaahara (Red-colored in printed module). The dietary items having mixed properties were advised to take occasionally (Blue colored in printed module). This module is easy and practical to follow for the patients of constipation [Table 1].
Clinical study
The dietary module for constipation was clinically tested to evaluate the laxative effect compared with Triphala Churna in the patients of constipation.
Interventions
- Group A (control): 3–6g (½ karsh) Triphala Churna was given orally at night after meal daily with lukewarm water. Medicine prepared in the National Institute of Ayurveda (NIA) pharmacy has been taken for this trial
- Group B (trial): Prescribed diet as per module as a daily diet.
Study setting
Source of data (population of interest)
Patients who were the suffering from constipation fulfilling the inclusion and exclusion criteria were randomly selected from NIA group of Hospitals, Jaipur.
- Total duration of trial: 18 months
- Recruitment period: 6 months
- Treatment period: 4 weeks
- Follow-up period: Weekly.
Research design:
- Type of study: Open randomized controlled trial
- Number of groups: Two
- Type of groups: Controlled and active
- Sample Size: 40 in each group
- Total number of patients: 80.
Drop out
Total eight patients, six patients in group A and two patients in group B, because those patients did not come for two consecutive follow-ups.
Ethical clearance
This study is ethically approved by IEC, NIA, Jaipur vide No. IEC/ACA/2018/54 dated May 11, 2018.
CTRI registration number: CTRI/2019/09/021411.
Diagnostic criteria
The following criteria were taken into consideration for the diagnosis of chronic constipation as defined by the American Gastroenterology Association.[13]
The presence of following conditions (two or more) for 12 weeks or more in the last 1 year.
- Straining one out of four defecations
- Lumpy or hard stool one out of four defections
- Sensation of incomplete evacuation
- Sensation of anorectic obstruction
- Manual maneuvers to facilitate defection
- <3 defecation per weeks.
Inclusion criteria
- Patients between 18 and 60 years and irrespective of gender and
- Patients fulfill the diagnostic criteria.
Exclusion criteria
- Patient taking Teekshna Virechana (Sanaya/Jayaphala preparation) since a long time
- Patients were on medications known to causes constipation such as opioid analgesics, antidepressants, and anticonvulsants
- Known case with a history of abdominal or anorectic surgery in the past 1 year
- Known case of renal or liver dysfunction or colonic inertia
- Known case of structural abnormalities of gastro-intestinal tract
- Known case of uncontrolled systemic ailments (HIV, diabetes mellitus, Tuberculosis)
- Neurological problems like Parkinson's disease, multiple sclerosis, sacral nerve damage, and paraplegia or autonomic neuropathy
- Pregnant and lactating women.
Withdrawal criteria
- The patients of either group those not following the drug (Triphala Churna) or prescribed dietary module more than 3 consecutive days.
- Any harmful effect like diarrhea in the patients.
Assessment parameters
Related to bowel habit
Weekly frequency of bowel movements, stool form, straining during defecation, sensation of incomplete bowel evacuation, sensation of anorectal blockage, and average time spend on toilet to bowel evacuation.
Weekly frequency of bowel movements is accessed on the basis of numbers, stool form is assessed on the basis of Bristol Stool Form Scale, Straining during defecation, Sensation of incomplete bowel evacuation, Sensation of anorectal blockage are assessed on the basis of visual analog scale score and average time spend on toilet to bowel evacuation is accessed in minutes.
Associated symptoms
Acidity (Amalpitta), Flatulence (Apanavayudusti), Headache (Shirashoola), Abdominal fullness (Atopa), Colic pain (Udarashoola), and Belching (Udgara).
All above Associated symptoms are assessed on the basis of self-grading from 0 to 3 (absent/mild/moderate/severe).
Outcomes of study
- A dietary module has been prepared on the basis of Ayurvedic principles
- The prescribed dietary module has been found effective in the management of constipation.
| Observations and Results | | |
Forty patients were registered in each group, out of them total of eight patients were dropped out, six patients in Group A and two patients in Group B. Remaining 34 patients of Group A and 38 patients of Group B completed the treatment successfully. The reason of dropout was to poor compliance of the patients.
Wilcoxon Signed-Rank Test was used to evaluate the effect of therapy on Intra-Group comparison. Very significant result as found in both groups on all assessment parameters except weekly frequency of bowel movements in which result was significant in Group A [Table 2]. | Table 2: Effect of therapy on intra-group comparison in Group-A and Group-B
Click here to view |
Mann–Whitney Test was used to evaluate the effect of therapy on intergroup comparison between Group and Group B. There was no significant difference in all assessment parameters except weekly frequency of bowel movements and colic pain (Udarashoola) where the effect was more in Group B. It indicates that both groups have almost equal effect however Group B has more effect on two parameters (frequency of bowel movements and colic pain) [Table 3]. | Table 3: Effect of therapy on inter-group comparison in Group-A and Group-B
Click here to view |
| Discussion | | |
Vibandha is initiated by vitiation of Apana Vata especially in people having vishamagni.[14] The Sanchita Vata further gets into Prakupita stage by VataVardhaka Nidana. SthanaSamshraya predominantly takes place in Pakvashaya being the seat of Apana Vayu. Vyaktavastha stage in Pakvashaya is the result of obstructing the movement of Pureesha known as Vibandha.
This Samprapti of Vibandha may be broken by avoiding causative factors (Nidana Parivarjana) to prevent Sanchayavasth[15] of Vata Dosha. Further stages of Samprapti may be checked by consuming Vatashamaka, Vatanulomaka, Rechaka, Sara, and Snigdha Ahara.
Following functions of large intestine may be compared with the functions of the Apana Vata[16] in the Pakvashaya:
- Absorption of water and electrolytes from the chyme to form solid feces-Shoshana
- Storage of fecal matter until it can be expelled out-Dharana, Stambhana
- Expulsion of the fecal matter through the anus-Viksepana.
The cause of Vibandha is vitiation of Apana Vata and Vishamagni. Therefore, Ahara Dravyas in dietary module were taken having Amla, Madhura, Usna, Vibandhahara, Vatahara, Snigdha, Sara, and Deepana properties. Keeping this concept in mind a printed dietary module was prepared and given to the patients to adopt the diet as advised.
According to Acharya Charaka describe that Madhura, Lavana and Amla Rasa on account of their Snigdha (unctuous) quality, are generally considered helpful in the elimination of flatus, urine, and feces. The Madhura rasa formed on postdigestion is promotive of Kapha and Amla Rasa formed on postdigestion promotes Pitta, both help in the elimination of feces and urine.[17] Ushna and Sara Dravyas are also used for Vibandha because its Anulomana properties. Contraindicated diet in Vibandha is Katu, Tikta, and Kashaya Rasaahara, on account of their dry quality they are found to render the elimination of flatus, urine, and feces difficult.[18]
The study was limited to small sample size. It was very difficult to access the compliance of the patients of Group B (Prescribed Dietary Module). In future, this study may be conducted with large sample size for more reliable results. The same study may be planned in indoor patients with monitored prescribed diet for better compliance as well as assessment.
| Conclusion | | |
- Very significant result was found in both groups on all assessment parameters except weekly frequency of bowel movements which result was significant in Group A
- There was no significant difference in all assessment parameters except weekly frequency of bowel movements and colic pain (Udarashoola) where the effect was more in Group B. It indicates that both groups have almost equal effect however Group B has more effect on two parameters
- No adverse effect was found in patients of any of the group
- Finally, it may be concluded that prescribed Pathya Ahara has a laxative effect in constipation; it may be used with medicines to improve the effect or alone to use for a longer duration safely.
Financial support and sponsorship
This study was supported by the National Institute of Ayurveda Jaipur.
Conflicts of interest
There are no conflicts of interest.
| References | | |
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| 2. | Talley NJ. Definitions, epidemiology, and impact of chronic constipation. Rev Gastroenterol Disord 2004;4 Suppl 2:S3-10. |
| 3. | Dennison C, Prasad M, Lloyd A, Bhattacharyya SK, Dhawan R, Coyne K. The health-related quality of life and economic burden of constipation. Pharmacoeconomics 2005;23:461-76. |
| 4. | Rathi B. A short study on pharmaceutical preparation & clinical evaluation of phalavarti (gudavarti) in malavrodha (constipation). J Indian Syst Med 2013;1:31-4. |
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| 13. | Constipation Guideline Patient Companion, Americal Gastroenterological Association. Available from: https://www.gastro.org. [Last accessed on 2019 Jun 21]. |
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[Table 1], [Table 2], [Table 3]
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