Role of indigenous Compound drugs in Grahni Roga(Irritable bowel syndrome)
Role of indigenous Compound drugs in Grahni Roga(Irritable bowel syndrome)
*Nirmal kumar, **Shweta, ***S.K.Tiwari
ABSTRACT:
INTRODUCTION: Grahani Roga is one of chronic disorder that hampers daily to daily life. Etiological factors responsible for same are those that causes diminution of Agni along with vitiation of tridosha, all leading to Ama formation and leading food to be in Vishtambha form. Some important causes are frequent intake of Heavy diet, Adhyashan, Ajirnashan, improper Vaman and Virechan as well as some factors like psychological stress. Main feature of disease is frequent passage liquid sometimes solid but necessarily Vishtambh mala. In modern science features of Grahni roga is quiet comparable with IBS.
IBS is as common as common cold. It has aptly been termed as "A dilemma within a dilemma surrounded by a dilemma". IBS is a chronic functional disorder of abnormal intestine without structural changes in gastrointestinal tract. It is characterized by altered bowel habits often associated with alteration of constipation and diarrhoea acocompained by abdominal pain.
* J unior Resident 3rd year ,deptt. Of Kayachikitsa,IMS,BHU
** Junior Resident 3rd year ,deptt. Of Kayachikitsa,
***Professor, deptt. Of Kayachikitsa,IMS,BHU
This condition is not associated with other organic-gastrointestinal diseases such as inflammatory bowel disease; gastro-esophageal reflux and peptic ulcer and does not shorten the life span of the patients.
IBS is a motility disorder of GIT essentially of functional nature with definite psychosomatic basis. It is usually a paroxysmal disturbance of bowel motility by an episodic motor dysarhythmia. It is a persistent syndrome intractable to all kinds of treatment and presentation often appears intermingled with a range of personality factors. In most of these patients there is no identifiable organic pathology and no single specific etiological factor is attributable to causation of this disease. The potential for abnormal function of the colon is always present in IBS patients but a trigger also must be present to cause symptoms. The most likely culprit seems to be diet and emotional stress As the IBS is a very common disorder but still no single test is sufficient to confirm the diagnosis. There are no laboratorial endoscopic or radiological investigations to provide positive diagnosis. As regards the principles of management of Grahni roga as per Ayurvedic system of medicine; it has been advocated that primarily the equilibrium of the three doshas is essential along with the normal functioning of Agni In Modern medicine general treatment of IBS includes administration of Antispasmodic and anticholinergic drugs, anxiolytics and antidepressants, opioids and bulking agents that often produce untoward, side-effects on long term administration. As regard the pharmacological remedy an Ayurvedic formulation KCAMP vati has been clinically evaluated in prescribed doses in cases of Grahni Roga( IBS). In present study the new Ayurvedic formulation has been undertaken for the single blind control clinical trial. The present new formulation did not show any side-effect even after prolonged administration.
The object of present series of study is to evaluate the beneficial effect of new ayurvedic formulation containing the organic extract of Kutaj, Chitrak, Ashwagandha, Musta & Jaljamani for the management of Grahni Roga (IBS).
MATERIAL AND METHOD:
The Grahni is the most common gastrointestinal disease in clinical practice and is posing a serious challenge for the physical and mental state of the patients. Herbal formulations have been observed to be effective, safe and less expensive in the management of this clinical entity.
Aim of the study
To find out the effect of Ghana (extract) of Kutaja, Chitrak, Ashwagandha, Musta and Patalgarudi in the Grahni Roga.
Method of the study (Clinical Trial)
Selection of the patients:
The patients were randomly selected from the Kayachikitsa OPD of S.S. Hospital, IMS, BHU. Altogether 100 patients were, found to possess symptomatology similar to the clinical picture of Grahni Roga. However after through investigation 40 patients were excluded and 60 patients were finally dignosed as Grahni roga. Thus 60 patients were treated by trial drugs.
Approach to the Clinical Studies:
Detailed clinical history of all the registered patients was noted in terms of following questionnaire, chief complaint with its duration, history of present illness, history of past illness, treatment and family history, occupational history and personal history.
Diagnostic Criteria:
We use mainly subjective criteria and also included Rome's criteria:
(i) Increased frequency of motion
(ii) Mucus with stool
(iii) Feeling of incomplete evacuation of bowel
(iv) Flatulence
(v) Pain in abdomen
Exclusion Criteria:
1. Inflamatory bowel disease 2. Dysentry
3. Diverticular disease 4. Malabsorption
5. Carcinoma colon 6. Carcinoma pancereas, pancreatitis
7. Alactasia (loctose intolerance) 8. Peptic ulcer and reflux esophagitis
9. Abdominal Koch’s
INVESTIGATIONS:
Patients are advised for stool examination through concentration method at least 3 samples up to 3 consecutive days, to evaluate the mucus, protozoa and any other things which is present in stool. Some other investigations were also done to assess the general condition of the patient and rule out other diseases. Those include blood for TLC, DLC, Hb, ESR, Urea, sugar and L.F.T., X-ray, Ba-enema.
Barium meal follow through has been performed in relevent subjects to exclude Koch’s abdomen.
Except the diagnostic criteria mentioned above, patients also complained of restlessness, heartburn, weakness, acidic eructation, belching, indigestion etc.
Criteria of Assessment:
An important aim of this clinical study was to evaluate the therapeutic effect of Ghana of Kutaja, Chitraka, Ashwagandha, Musta and Patal-garudi in all cases of Grahni Roga. A final assessment was done of clinical symptomatology and stool picture after three follow up of drug therapy. The overall result of the study was categorized into four groups viz., Excellent, Moderate, mild and Unchanged. The details of criteria are given below:
(1) Excellent: The number of motions within 3 month coming to 1 to 2 per day and mucus in stool became absent, with other symptomatic improvement more than 75%.
(ii) Moderate: The number of motion within 3 month coming to normal and reduced amount of mucus in stool with other symptomatic improvement more than 50%.
(iii) Mild: Either number of motions or mucus in stool came to normal with other symptomatic improvement more than 25%.
(iv) Unchanged: No improvement in either the number of motions per day or mucus in stool, irrespective of other general symptomatic improvement.
Gradation of Symptomatology:
(1) Frequency of motion
| Nil | = | 0 | = | 1-2 motion/day |
| Mild | = | 1 | = | 3 to 5 motion/day |
| Moderate | = | 2 | = | 6 to 8 motion/day |
| Severe | = | 3 | = | >8 motion/day |
(2) Sense of incomplete evocuation
| Nil | = | 0 | = | Never |
| Mild | = | 1 | = | Occasional |
| Moderate | = | 2 | = | Often |
| Severe | = | 3 | = | Always |
(3) Mucus in stool
| Nil | = | 0 | = | No mucus |
| Mild | = | 1 | = | Often little amount |
| Moderate | = | 2 | = | Every time little amount |
| Severe | = | 3 | = | Every time large amount |
(4) Flatulance
| Nil | = | 0 | = | Never |
| Mild | = | 1 | = | Occasional |
| Moderate | = | 2 | = | Intermittent |
| Severe | = | 3 | = | Always |
(5) Pain in abdomen
| Nil | = | 0 | = | Never |
| Mild | = | 1 | = | Occasional |
| Moderate | = | 2 | = | Mild pain intermittent or tensmus during passing stool. |
| Severe | = | 3 | = | Always |
METHOD OF PREPARATION OF DRUG
1. KCAMP vati
Small pieces of dried bark of kutaj weighing 1o kg was soaked in 100 liters of water for whole night. In morning the whole soaked material along with same amount of water was boiled till the 50 liter of water evaporated. This 50 liter decoction was heated till the formation of GHANA. Then ghana was dried in sun rays.
In the same way root of Chitrak, Ashwagandha, whole plant of Musta and Jaljamni was taken and GHANA of each was prepared separately in same fashion. Now equal amounts of GHANA of Kutaj, Ashwagandha, Chitrak, Musta and Jaljamani was mixed and vati was prepared weighing 500 mg as per single dose.
2. Placebo (lactobacillus)
METHOD OF ADMINISTRATION OF DRUG
1. GROUP I : - 2 KCAMP vati three times a day orally with luke warm water.
2. GROUP II : - 2 KCAMP vati three times a day orally with TAKRA.
3. GROUP III : - 2 KCAMP vati three times a day orally with TANDULODAK.
4. GROUP IV: - 2 Capsule three times a day orally with plain water.
Single blind control trial:-
The trial is so planned that patient is not aware of the group allocation.
OBSERVATION and RESULTS:
The patients which are included in this study were consulting from the Department of Kayachikitsa, S.S. Hospital, B.H.U. All the 100 patients were taken for the study.
A total of 100 patients presented with the symptoms which are more or less in line with symptoms of Grahni roga. Moreover all the 100 patients were fiting in Grahni roga symptom criteria and thus clinically taken as Grahni Roga.
However again through investigation it was found that 40 patients were to have positive evidence for parasitic infestations and chronic disease as abdominal tuberculosis as mentioend in following table.
Table No. 1: Show the effect of trial drugs on frequency of motion in 60 cases of Grahni Roga(IBS):
| Group | B. T. | A. T. | Difference | Paired t/p | Unpaired (t/p) | ||
| Mean±SD | Mean±SD | Mean±SD | Group I Vs Group IV | Group II Vs Group IV | Group III Vs Group IV | ||
| Group I | 1.86±0.74 | 0.86±0.64 | 1.0±0.53 | 7.25 P<0.001 | 1.32 P>0.05 | 0.46 P>0.05 | 2.26 P<0.05 |
| Group II | 2.20±0.67 | 1.06±0.88 | 1.13±0.74 | 5.91 P<0.001 | | | |
| Group III | 1.53±0.83 | 0.66±0.61 | 0.86±0.74 | 4.52 P<0.001 | | | |
| Group IV | 1.42±0.85 | 1.14±0.94 | 0.28±0.46 | 2.28 P<0.05 | | | |
Group I :- Patients treated with KCAMP vati and luke warm water.
Group II :- Patients treated with KCAMP vati and Takra.
Group III :- Patients treated with KCAMP vati and Tandulodak.
Group IV :- Patients treated with Placebo capsule ( chana powder ).
Statistically significant improvement was observed in Group I, Group II & Group III . Mean reduction of the difference is 1.0±0.53, 1.13±0.74, 0.86±0.74 & 0.28±0.46 in trial groups I, II, III & IV respectively. Statistical analysis revealed that the difference was highly significant in groups I, II & III and significant in group IV.
In inter-group comparison group III therapy has produced Statistically significant result in comparision to other groups.
Table No. 2: Show the effect of trial drugs on Sense of incomplete evacuation in 60 cases of Grahni Roga (IBS):
| Group | B. T. | A. T. | Difference | Paired t/p | Unpaired t/p | ||
| Mean±SD | Mean±SD | Mean±SD | Group I Vs Group IV | GroupII Vs Group IV | GroupIII Vs Group IV | ||
| Group I | 1.66±0.90 | 0.86±0.64 | 0.80±0.41 | 7.48 P<0.001 | 4.78 P<0.001 | 4.58 P<0.001 | 4.53 P<0.001 |
| Group II | 2.00±0.84 | 1.00±0.75 | 1.00±0.37 | 10.25 P<0.001 | | | |
| Group III | 1.53±0.83 | 0.80±0.67 | 0.73±0.45 | 6.20 P<0.001 | | | |
| Group IV | 1.86±0.99 | 1.60±1.05 | 0.26±0.45 | 2.26 P<0.05 | | | |
Group I :- Patients treated with KCAMP vati and luke warm water.
Group II :- Patients treated with KCAMP vati and Takra.
Group III :- Patients treated with KCAMP vati and Tandulodak.
Group IV :- Patients treated with Placebo capsule ( chana powder ).
Statistically significant improvement was observed in Group I, Group II & Group III . Mean reduction of the difference is 0.80±0.41, 1.00±0.37, 0.73±0.45 & 0.26±0.45 in trial groups I, II, III & IV respectively. Statistical analysis revealed that the difference was highly significant in groups I, II, III and also in group IV.
In inter-group comparison group III therapy has produced Statistically significant result in comparision to other groups.
Table No. 3: Show the effect of trial drugs on mucus in stool in 60 cases of Grahni Roga (IBS):
| Group | B. T. | A. T. | Difference | Paired t/p | Unpaired t/p | ||
| Mean±SD | Mean±SD | Mean±SD | Group I Vs Group IV | Group II Vs Group IV | Group III Vs Group IV | ||
| Group I | 1.46±0.83 | 0.66±0.61 | 0.80±0.41 | 7.48 P<0.001 | 4.78 P<0.001 | 3.50 P<0.05 | 2.65 P<0.05 |
| Group II | 2.00±0.84 | 0.93±0.88 | 1.06±0.53 | 6.96 P<0.001 | | | |
| Group III | 1.66±0.97 | 1.06±1.03 | 0.60±0.50 | 4.58 P<0.001 | | | |
| Group IV | 1.66±1.04 | 1.40±1.05 | 0.26±0.45 | 2.26 P<0.05 | | | |
Group I :- Patients treated with KCAMP vati and luke warm water.
Group II :- Patients treated with KCAMP vati and Takra.
Group III :- Patients treated with KCAMP vati and Tandulodak.
Group IV :- Patients treated with Placebo capsule ( chana powder ).
Statistically significant improvement was observed in Group I, Group II & Group III . Mean reduction of the difference is 0.80±0.41, 1.06±0.53, 0.60±0.50 & 0.26±0.45 in trial groups I, II, III & IV respectively. Statistical analysis revealed that the difference was highly significant in groups I, II, III and in group IV also significant.
In inter-group comparison group I therapy has produced Statistically significant result in comparision to other groups.
Table No. 4: Show the effect of trial drugs on Flatulance in 60 cases of Grahni Roga (IBS):
| Group | B. T. | A. T. | Difference | Paired t/p | Unpaired t/p | ||
| Mean±SD | Mean±SD | Mean±SD | Group I Vs Group IV | Group II Vs Group IV | Group III Vs Group IV | ||
| Group I | 1.46±0.99 | 0.53±0.64 | 0.93±0.59 | 6.09 P<0.001 | 4.58 P<0.001 | 3.50 P<0.05 | 3.50 P<0.05 |
| Group II | 2.00±0.84 | 0.66±0.72 | 1.33±0.61 | 8.37 P<0.001 | | | |
| Group III | 1.26±0.96 | 0.66±0.72 | 0.60±0.50 | 4.58 P<0.001 | | | |
| Group IV | 1.66±1.04 | 1.13±.91 | 0.53±0.51 | 4.00 P<0.05 | | | |
Group I :- Patients treated with KCAMP vati and luke warm water.
Group II :- Patients treated with KCAMP vati and Takra.
Group III :- Patients treated with KCAMP vati and Tandulodak.
Group IV :- Patients treated with Placebo capsule ( chana powder ).
Statistically significant improvement was observed in Group I, Group II & Group III. Mean reduction of the difference is 0.93±0.59, 1.33±0.61, 0.60±0.50 & 0.53±0.51 in trial groups I, II, III & IV respectively. Statistical analysis revealed that the difference was highly significant in groups I, II, III and in group IV also significant.
In inter-group comparison group I therapy has produced Statistically significant result in comparision to other groups.
Table No. 5: Show the effect of trial drugs on Pain in abdomen in 60 cases of Grahni Roga (IBS):
| Group | B. T. | A. T. | Difference | Paired t/p | Unpaired t/p | ||
| Mean±SD | Mean±SD | Mean±SD | Group I Vs Group IV | Group II Vs Group IV | Group III Vs Group IV | ||
| Group I | 1.60±0.73 | 0.53±0.51 | 1.06±0.45 | 9.03 P<0.001 | 3.23 P<0.05 | 3.06 P<0.05 | 1.00 P>0.05 |
| Group II | 1.46±0.99 | 0.66±0.72 | 0.80±0.41 | 7.48 P<0.001 | | | |
| Group III | 1.53±1.06 | 1.0±0.92 | 0.53±0.51 | 4.00 P<0.05 | | | |
| Group IV | 1.46±1.06 | 1.06±.88 | 0.40±0.50 | 3.06 P<0.05 | | | |
Group I :- Patients treated with KCAMP vati and luke warm water.
Group II :- Patients treated with KCAMP vati and Takra.
Group III :- Patients treated with KCAMP vati and Tandulodak.
Group IV :- Patients treated with Placebo capsule ( chana powder ).
Statistically significant improvement was observed in Group I, Group II & Group III . Mean reduction of the difference is 1.06±0.45, 0.80±0.41, 0.53±0.51 & 0.40±0.50 in trial groups I, II, III & IV respectively. Statistical analysis revealed that the difference was highly significant in groups I & II and in group III & IV also significant.
In inter-group comparison group I therapy has produced Statistically significant result in comparision to other groups.
Table No. 21: Total response of trial drug in 60 patients of Grahni Roga (IBS):
| Group | Excellent | Moderate | Mild | Unchanged | ||||
| No. | % | No. | % | No. | % | No. | % | |
| Group I | 04 | 26.66 | 03 | 20 | 05 | 33.33 | 03 | 20 |
| Group II | 06 | 40 | 03 | 20 | 04 | 26.66 | 02 | 13.33 |
| Group III | 02 | 13.33 | 04 | 26.66 | 05 | 33.33 | 04 | 26.66 |
| Group IV | 00 | 00 | 00 | 00 | 07 | 46.66 | 08 | 53.33 |
Out of 60 cases of Grahani Roga (IBS) excellent result was observed in 26.66%, 40%, 13.33% & 0% respectively in Group I, II, III & IV.
Moderate result was observed in 20%, 20%, 26.66% & 0% respectively in Group I, II, III & IV. Mild result was observed in 33.33%, 26.66%, 33.33% & 46.66% respectively in Group I, II, III & IV.
Where as there was no improvement was observed in 20%, 13.33%, 26.66% & 53.33% respectively in Group I, II, III & IV.
The response obtained in Group II was considerably higher compared to other groups.
DISCUSSION:
A total of 100 patients presented the clinical picture similar to the Grahni Roga (IBS) satisfying Romes criteria. However among them 40 patients were found to have positive evidence of parasitic infestations & other long term illness and were excluded from the study. This finding shows that majority of patients suffering from parasitic infestation also present the same clinical picture as that of Grahni Roga (IBS). Therefore it becomes mandatory to exclude parasitic infestation before labeling the diagnosis of IBS. A total of 60 patients, satisfying diagnostic criteria of Grahni Roga (IBS) were registered and subjected with trial drug therapy, on random basis.
Total duration of trial therapy was 3month with regular followups at 30 days interval. Following clinical parameters were assussed before treatment and at each followup. They included ferequecny of motions, mucoid stool, incomplete evacuation, flatulence, and pain in abdomen,
The clinical grading scores of all the above parameters were assessed and recorded in the protocol prepared for this purpose.
Intra-group comparison was done between group I (KCAMP vati with luke warm water), group II (KCAMP vati with takra), group III (KCAMP vati with tandulodak) and between group IV (placebo). Each group comprising of 15 patients .
Frequency of motion was considerably reduced in all groups (t=7.25, 5.91, 4.52 & 2.28 respectively). On intra-group comparison with placebo group response obtained was more in group III than group I and II.
Mucoid stools of patients group I, II and III improved after trial therapy. Statistically significant results were obtained in these groups. However intra-group comparison of group I is more significant than other groups.
Initial mean of incomplete evacuation reduced after trial therapy in group I, II, and III. On intra-group comparison group II therapy has been statistically more significant compared to group I and group III.
Statistically significant result was obtained in group I, II and group III in flatualence, and abdominal pain. In group IV therapy statistically insignificant (in some symptom mild significance) result was observed. Intra-group comparison of group II was significant over group I & III and group I & III over group IV. But statistically this is not defined.
Thus in most of all clinical parameters the KCAMP vati therapy was significant compared to that of placebo treated group.
CONCLUSION:
The present study entitled ‘Role of indigenous Compound drugs in Grahni Roga (IBS)’’ was undertaken with following objectives.
a) Critical literary and conceptual study of disorders simulating Grahni Roga in Ayurveda.
b) Single blind controlled clinical study of an Ayurvedic compound KCAMP vati with diff. Anupan in the patients of Grahni Roga.
The clinical picture of Grahni Roga in Ayurveda. appeared more nearer and more appropriate to the clinical symptomatology of IBS.
The total duration of trial therapy was of 90 days with regular followup.
The clinical parameter assessed by making clinical grading scores at each followup. Relevant investigations performed to exclude other related disorders.
The KCAMP vati contained an extract of kutaj, chitrak, ashwagandha, musta and jaljamani. The placebo capsule was filled with lactobacillus.
Statistical analysis of trial drugs in various parameters reveals that the significant improvement of group I, II and III patients in all clinical parameters such as frequency of motion, mucoid stool, incomplete evacuation, flatulence, and pain abdomen scores.
Minor changes were recorded with placebo treated group on intragroup comparison. Response obtains with group II therapy was more when compared with other group.
Thus trial drugs with different anupan possessed mild to moderate effect in Grahni Roga (IBS) patients. However it is suggested that further clinical trial should be undertaken to evaluate the response in longer sample cases.
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