Gavali et al. World Journal of Pharmaceutical Research
A OPEN RANDOMIZED COMPARATIVE CLINICAL TRIAL OF
HARITAKYADI CHURNA IN THE MANAGEMENT OF URDHVAGA
AMLAPITTA WITH AND WITHOUT DIET RESTRICTION.
1*
Dr. Amit Gavali, 2Medha Joshi and 3Prafulla Katkar
1
MD Kayachikitsa, 2Associate Professor Kayachikitsa, 3PG Scholar Kayachikitsa, P.D.E.A’S College of Ayurveda and Research Center, Nigdi, Pune.
ABSTRACT
Urdhvaga Amlapitta is a challenge to treat because of its recurrence
nature due to faulty dietary habits. Conventional modern management
in such condition shows side effects. Such conditions can be treated
successfully, if ayurvedic principles mentioned in treatment of
Amlapitta are followed. Amlapitta is a disease caused due to vitiation
of certain attributes of Pitta like the Drava guna (fluidity) and Amla
guna (sourness) causing Vidagdhajirna at the initial stages and later
causes inflammation and corrosion of the Sleshmadhara kala (mucosa)
of the Amashaya (stomach) i.e. mucous membrane of the stomach and
duodenum. Hyperacidity can be correlated with Urdhvaga Amlapitta
according to ayurveda. In this study total 60 patients of Urdhvaga
Amlapitta were registered. They were divided into two groups and treated with 1)
Haritakyadi Churna 3 gm BD with diet restriction for 30 days. 2) Haritakyadi Churna 3 gm
BD without diet restriction for 30 days. The patients were subjected to evaluation of cardinal
sign and symptoms of Amlapitta on the basis of grades according to the severity before and
after treatment. The results showed that the effect of Haritakyadi churna is better with diet
restriction as compared to that of without diet restriction in the treatment of Amlapitta.
KEYWORDS: Amlapitta, Haritakyadi churna, Hyperacidity. INTRODUCTION
Ayurvedic samhitas have described healthy routine under dinacharya & rutucharya but in
present scenario due to busy life style people are unable to follow the norms of dinacharya
and rutucharya resulting in agnimandya which ultimately lead to diseases like Amlapitta.
Volume 5, Issue 4, 1214-1224. Research Article ISSN 2277– 7105
*Correspondence for
Author
Dr. Prafulla Katkar
PG Scholar Kayachikitsa,
P.D.E.A’S College of
Ayurveda and Research
Center, Nigdi, Pune. Article Received on 28 Jan 2016,
Revised on 18 Feb 2016, Accepted on 10 March 2016
In this modern world the human life has completely changed due to development of
industries and fast business life due to which people are having adverse effects on their health
and even suffering from ailments because of increased ingestion of tea, sour, oily, spicy food,
cold drinks, alcohol, tobacco, smoking, irregular time of food and sleep habits, irritant drinks
and indulgence towards western life style. Also consumption of drugs like aspirin, NSAIDS
and antibiotics is increased which creates bad effects on our digestion. It causes burning
sensation, irritation to gastric mucosa besides this psychic emotions like passion, anger, greet
fear etc which leads to amlapitta. Thus mithya ahar (improper diet), mithya vihar and
pradnyaparadha are the main etiological factors for any disease. Clinical management of
Amlapitta according to Ayurveda is based on jatharagni and tridosha.
When jatharagni gets vitiated then it also vitiates dhatvagni which leads to diseases like atisar
(diarrhea), visuchika (cholera), grahani (irritable bowel syndrome), amlapitta (hyperacidity)
etc. Day by day the science is upgrading itself but also on the other hand it has a side effect
on our health.
Amlapitta is described in detail in Kashyapa Samhita and Laghutrayi. Various shaman kalpa
are described in Amlapitta chikitsa which are established from time to time.
AIM AND OBJECTIVES Aim
To study the effect of Haritakyadi Churna in the management of Urdhvaga Amlapitta with
and without diet restriction.
Objectives
Primary Objective
To study the efficacy of Haritakyadi Churna in Urdhvaga Amlapitta with and without Diet
restriction.
Secondary Objective
To study the adverse effect of Haritakyadi Churna if any.
MATERIALS AND METHODS Review of Drug
Ingredients
Ingredients of Haritakyadi Churna are
1) Haritaki (Bal Hirada).
2) Pimpli (navak pimpli).
3) Seeta (Khadisakhar).
4) Dhanyak (Hirave Dhanyak).
5) Drakshak (kale Manuke).
6) Vasak (Dhamasa).
LITERARY REVIEW
The references of Urdhvaga Amlapitta from Brihatrayi, Laughutrayi and Vedas are studied
and complied.
CLINICAL STUDY
This is an open, randomized clinical study without control. Patients were selected above 16
yrs irrespective of sex, religion, occupation, etc. The study was conducted for 1 month and
follow up was taken after 10th day, 20th day, 30th day from the OPD & IPD of Kayachikitsa department of CARC Ayurveda Rugnalaya, Akurdi.
A total of 60 patients were enrolled for this study who were divided into two groups A and B
of 30 patients each.
Group A treated with Haritakyadi Churna with diet restriction.
Group B was treated with Haritakyadi Churna without diet restriction.
STUDY DESIGN
Study design is an open, randomized, clinical study without control. Haritakyadi Churna was
used in study group along with Honey as an anupana.
PLACE OF STUDY
All the patients having signs and symptoms of Urdhvaga Amlapitta were selected and
enrolled in the study from the kayachikitsa OPD, IPD of Kayachikitsa department of CARC
Ayurveda Rugnalaya, Akurdi.
DRUG AND ROUTE OF ADMINISTRATION.
Drug Group –A Group- B
Dose 3 gm BD 3 gm BD
Bheshaj kala Madhye-Bhukta Madhye-Bhukta (After half meal) (After half meal)
Duration 30 days 30 days
Follow up 10th , 20th , 30th 10th , 20th , 30th
Anupan Honey Honey
Special consideration with diet restriction without diet restriction
SUBJECTIVE CRITERIA 1] Chhardi (vomiting).
2] Amlodgar (irructations).
3] Shirashool (Headache).
4] Kantha-hruda-kukshi-Daha (throat and heart burn).
5] Atopa (fullness in abdomen).
6] Kandu (itching).
7] Mandalotpatti (urticarial wheels).
8] Hastapada-Daha (burning sensation in palm and foot).
9] Jwara (fever).
INCLUSION CRITERIA
Age group above 16yrs.
Patients having signs & symptoms of Urdhvag Amlapitta.
Patients from all socio-economic status.
EXCLUSION CRITERIA
× Patients with severe vomiting & diarrhoea. × In pregnancy.
× Patients with perforated peptic ulcer & those who need surgical interventions. × Pre-diagnosed Lax Hiatus, H. Pylori infection.
CRITERIA FOR WITHDRAWAL
1) Those patients who will show any adverse reaction of the drug.
2) Patients who are not under scheduled follow up.
CRITERIA OF ASSESSMENT
1] Chhardi (Vomiting).
Grade Score Signs & symptoms +++ 3 Above 5 in a week
++ 2 3-5 in a week + 1 1-2 in a week 0 0 Absent.
2] Amlodgar (irructations).
Grade Score Signs & symptoms
+++ 3 Persistent throughout the day. ++ 2 After meal.
+ 1 Occasional. 0 0 Absent.
3] Shirashool (Headache).
Grade Score Signs & symptoms
+++ 3 Persistent throughout the day. ++ 2 3-4 times a day.
+ 1 Occasional. 0 0 Absent.
4] Kantha-hruda-kukshi-Daha (throat and heart burn). Grade Score Signs & symptoms
+++ 3 Persistent throughout the day. ++ 2 After meal.
+ 1 Occasional. 0 0 Absent.
5] Atopa (fullness in abdomen).
Grade Score Signs & symptoms
+++ 3 Persistent throughout the day. ++ 2 After meal.
+ 1 Occasional. 0 0 Absent.
6] Kandu (itching).
Grade Score Signs & symptoms +++ 3 Persistent throughout.
++ 2 3-5 times a day. + 1 Occasionally. 0 0 Absent.
7] Mandalotpatti (urticarial wheels).
Grade Score Signs & symptoms
++ 2 After meal. + 1 Occasional. 0 0 Absent.
8] Hastapada-Daha (burning sensation in palm and foot). Grade Score Signs & symptoms
+++ 3 Persistent throughout the day. ++ 2 3-4 times a day.
+ 1 Occasional. 0 0 Absent.
9] Jwara (fever).
Grade Score Temperature +++ 3 More than 1020f
++ 2 1000f - 1020f + 1 980f - 1000f 0 0 Less than 980f
OVERALL SCORE
1 – 9 Mild Grade I 10 – 18 Moderate Grade II 19 – 27 Severe Grade III
RELIEF OF SYMPTOMS Good Results : No any complaints.
Moderate Results : 2 steps down.
Mild Results : 1 steps down.
No Results : No change in complaints.
RESULT IN PERCENTAGE
% Result
0 No improvement 1-25 Poor
26-50 Average 51-75 Good 76-100 Excellent
RELIEF OF SYMPTOM
Patient was assessed during treatment and result has been drawn.
Good Results : No any complaints.
Moderate Results : 2 steps down.
No Results : change in complaints.
OBSERVATIONS AND RESULTS
Table – 1: Age wise distribution of 60 patients of Amlapitta.
Age (years) Group-1 Group-2 Total Percent
16-30 5 9 14 23.33
30 - 14 14 28 46.66
40 - 4 5 9 15
50 + 7 2 9 15
Table – 2: Occupation wise distribution of 60 patients of Amlapitta. Occupation Group-1 Group-2 Total Percent
Housewife 11 06 17 28.33%
Service 08 13 21 35.00%
Business 07 06 13 21.26%
Student 04 05 09 15.00%
Table – 3: Diet wise distribution of 60 patients of Amlapitta.
Diet Group-1 Group-2 Total Percent
Veg O9 05 14 23.33%
Mix 21 25 46 76.66%
Table – 4: Addiction wise distribution of 60 patients of Amlapitta. Addiction Group-1 Group-2 Total Percent
Nil 13 11 24 40
Smoking 5 7 12 20
Alcohol 5 3 8 13.33
Tobacco 2 5 7 11.66
Tea 15 14 29 48.33
Table – 5: Agni wise distribution of 60 patients of Amlapitta.
Agni Group-1 Group-2 Total Percent
Samagni 00 00 00 00.00%
Mandagni 18 24 42 70%
Tikshanagni 1 2 3 5%
Visamagni 11 4 15 25%
Table - 6: Sleeping Habit during day time - wise distribution of 60 patients of Amlapitta.
Sleep Group-A Group-B Total Percent
Excessive 3 3 6 10%
Intermittent 10 9 19 31.66%
Less 5 7 12 20%
Effect of Study on individual criteria’s of Assessment in Trial and Control Groups according to gradations
Total Score. Total score
Day-1 Day-30
% Relief
Wilcoxon Signed Ranks Test
Z
P Mean
score Sd
Mean
score Sd
Group-A 19.20 2.496 4.0 1.875 79.2 4.792 <0.001 HS Group-B 17.067 2.083 8.100 2.123 52.5 4.790 <0.001 HS
SYMPTOMWISE RELIEF
OVERALL EFFECT
Out of 60 patients most of the patients have moderate changes in their symptoms. But among
30 patients in Trial group 20 patients shows good improvement while 9 patients shows
moderate improvement. Among 30 patients in control group 17 patients shows moderate
improvement and 12 patients shows mild changes.
Comparison of effects between Trial and Control Group according to gradation Total score.
Total score Mean difference
score Sd
Mann-Whitney Z P Group-A 15.2000 3.19914 5.884 <0.001 HS
Symptoms % Relief
Group-A Group-B
Jwara (fever) 72.6 45.2
Chardi (vomiting) 71.7 50.0
Amlodgar (irructations) 84.1 68.7
Kantha-hruda-kukshi-Daha (throat and
heart burn) 84.5 64.3
Sheerashoola (headache) 76.9 54.4
Atoopa (fullness in abdomen) 83.1 44.8
Kandu (itching) 78.7 44.4
Mandalootpati (urticarial wheels) 82.8 45.2 Hasta-Pada-Daha (burning sensation in palm
and foot) 76.6 53.2
Total Score 79.2 52.5
Overall Effect Group-A Group-B
No change (<25%) 0 0
Mild change (25% – 49.9%) 1 12
Moderate change (50% -74.9%) 9 17
For Total score Zvalue is 5.884 & P value is <0.001 so it is highly significant.
DISCUSSION
Discussion Regarding Mode of Action of Drug
Amlapitta is mainly Pitta-Vata doshatmak and Abhyantar marga-gata vyadhi. In this disease
mainly Gastro-intestinal system is involved. According to various Samhitas, Pitta gets
vitiated by Ushna guna (hot property), Drava Guna (liquid property) and Amla guna (sour
taste).
As explained above, Amlapitta is Pitta-Vata doshatmak vyadhi, most of the drugs of
“Haritakyadi churna” are Madhur (sweet), Tikta (bitter) and Kashay (astringent) rasatmak are
Described as Pitta-shamak Rasa in Samhitas. Madhura vipaka of all Davyas of Haritakyadi
churna acts on Laghu guna because Madhur rasa has property of guru guna, so vitiated laghu
guna is antagonized by guru guna of Madhur vipaka of all drugs. Snigdha and guru guna of
Haritakyadi churna mainly acts on vitiated vata guna of amlapitta.
In Amlapitta Amlodgar is a symptom occured due to increase in Drava guna of vitiated Pitta.
So Ruksha guna of Haritaki antagonizes the Drava guna of vitiated pitta. Haritaki has its own
Anulomana property which is most beneficial in Urdhvag Amlapitta.
Sheet virya of both Draksha and Seeta acts on Ushna guna of vitiated Pitta. Draksha has also
Anulomana property which helps to pacify amlodgar with Haritaki. And effect of Ruksha
guna of Haritaki is controlled by Snigdha, Mrudu guna of Draksha and other drugs.
From above results Pathya-Apathya has additive effect with drug in Abhyantar marga-gata
vyadhi like Amlapitta, so it is found that pathya-apathya have prime role in Amlapitta.
All above findings of statistical analysis are suggestive that Haritakyadi churna is effective in
both groups but in comparative study, Haritakyadi churna is highly significant with diet
restrictions than without diet restrictions except Amlodgar.
Because Ruksha guna of Haritaki and Anulomana property of both Haritaki and Draksha
effectively act on Drava and urdhva guna of Amlodgar symptom. Kandu and
Hasta-pada-Daha shows only significant result in comparative study because these symptoms are not
According to the Statistical data
For statistical analysis of the data, Wilcoxon Signed Ranks Test Z and Mann-Whitney Z test
were applied.
Among all the signs and symptoms of urdhvaga Amlapitta Z value in trial group (according
to gradation) has shows 78.64% result in all of the assessment criterias so statistically Haritakyadi churna with diet restriction is effective in urdhavaga amlapitta while z value in
control group has shows 52.29% result, so statistically Haritakyadi churna without diet restrictions is also effective in Urdhvaga amlapitta. But in comparative study of both groups,
with diet restriction group is significantly effective than without diet restriction group. This
relief was noted mainly due to pathya-apathyakar ahar vihar chart explained to the patients of
the group A in present study.
CONCLUSION
After analyzing all the data and the observation, we conclude that administration of Haritakyadi churna is effective in Urdhvaga Amlapitta.
The effect of Haritakyadi churna is better with diet restriction as compared to that of
without diet restriction in the treatment of Amlapitta. No adverse effect was found during & after the study.
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