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2020| July-September | Volume 41 | Issue 3
Online since
February 24, 2022
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ORIGINAL ARTICLES - CLINICAL RESEARCH
Efficacy of
Brimhana Nasya
and
Ashwagandha (Withania somnifera
(L.) Dunal) root powder in primary insomnia in elderly male: A randomized open-label clinical study
Upadhyay Atul, Bansal Charu, Shukla Umesh
July-September 2020, 41(3):159-165
DOI
:10.4103/ayu.AYU_177_19
Background:
Decreased ability to fall asleep and/or stay asleep with daytime effects of sleep deprivation is identified as primary insomnia. Elderly due to the predominant
Vata Dosha
in the body are easily affected by this problem.
Brimhana Nasya
(nourishing nasal drop) with
Ksheera Bala Taila
and oral administration of
Ashwagandha
(
Withania somnifera
(L.) Dunal) root powder both are indicated in Ayurvedic classics for the management of insomnia.
Aim:
To determine the combined efficacy of oral administration of
Ashwagandha
root powder along with
Brimhana Nasya
with
Ksheera Bala Taila
in primary insomnia in geriatric.
Materials and methods:
This was randomized, open-label clinical study conducted at the hospital of Pt. Khushilal Sharma Government Ayurveda College and Institute Bhopal. Randomly selected 60 elderly patients with primary insomnia were randomly divided into two groups (30 in each group). Pittsburgh Sleep Quality Index was used to assess the symptoms of primary insomnia. Relief in the subjective symptoms was assessed in percentage. Then, the statistical significance of result within the group was assessed using Wilcoxon matched-pairs signed-ranks test and the comparative effect of therapy in both groups was assessed using Mann-Whitney test. Graph Pad InStat-3 software was used for statistical analysis.
Results:
On subjective sleep quality 86.66% relief with
P
< 0.0001, on sleep latency 60.02% improvement with
P
< 0.0001, improvement in sleep duration was reported in 89.15% of patients with
P
< 0.0001 and improvement in sleep efficiency was reported in 90.14% of patients with statistically extremely significant
P
< 0.0001 were observed in combined therapy group (
Ksheera Bala Taila Brimhana Nasya
along with oral administration of
Ashwagandha
root powder
).
While 38.66% improvement in sleep efficiency, 40.39% relief in sleep disturbances and 37.05% improvement on subjective sleep quality was reported in group B patients, i.e.,
Ashwagandha
root powder group.
Conclusion:
In 30 days treatment combined therapy was found more effective in the management of primary insomnia in the elderly compared with
Ashwagandha
root powder alone.
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312
Role of
Laksha Churna
and
Madhu Pratisarana
after ultrasonic scaling in the management of
Dantasharkara
(dental calculus): An open-label, standard controlled randomized clinical trial
Divyarani Kathad, Hemangi N Shukla, Mandip Goyal
July-September 2020, 41(3):173-180
DOI
:10.4103/ayu.AYU_274_20
Background:
Dental calculus is one of the major problems in dentistry, which is characterized by calcified mass that forms on and adheres to the surface of teeth resulting in bad breath, receding gums and chronically inflamed gingiva. It can be correlated with
Dantasharkara
(dental calculus), which is characterized by the collection of hardened accumulation of
Mala
(tartar) at the junction of teeth and gums. Ultrasonic scalars are used for the removal of dental calculus for convenience. In texts,
Laksha Churna
(powder of
Laccifer lacca
Kerr) has been mentioned as
Vranaropaka
(wound healing) and indicated for the eliminating plaque through cleaning and polishing tooth surfaces.
Aim:
This study was aimed to evaluate the clinical efficacy of local application of
Laksha Churna
and
Madhu
(honey)
Pratisarana
after
Dantasharkara Nirharana
(scaling of dental calculus) in the management of
Dantasharkara
(dental calculus).
Materials and methods:
Patients having calculus deposition, fulfilling the inclusion criteria were selected. In group A,
Pratisarana
with
Laksha Churna
(powder) 1 g and
Madhu
as per requirement was given, whereas in group B, chlor-hexidine gluconate 0.2% for gargling was given for 2 weeks. Ultrasonic scaling was done in both groups before given trial drugs. The outcomes were calculated on the base on changes in score of the subjective parameters like pain, inflammation of gum, bleeding gums, halitosis as well as objective parameters like oral hygiene index, debris index, calculus index, gingival index, and periodontal index. For analysing the effect of the result, Wilcoxon signed-rank test for nonparametric paired data and paired t-test for quantitative parametric paired data was applied.
Results:
After analysing the data, it was found that Ultrasonic scaling of dental calculus followed by
Pratisaraņa
of honey with
Laksha Churna
provided statistically significant improvement in calculus index (97.77%) in debris index (84.44%), in oral hygiene index(96.66%), in gingival index (83.33%)and showed 96.15% improvement in periodontal index, whereas Ultrasonic scaling of dental calculus followed by gargling with chlorhexidine gluconate 0.2% provided 80% improvement in calculus index, 70% in debris index, 90% in oral hygiene index, in gingival index by 73.06%, and 93.75% improvement periodontal index which was statistically significant.
Conclusion:
The present study indicates
Dantasharkara Nirharana
followed by
Pratisarana
of
Laksha Churna
and
Madhu
is comparatively more effective than conventional standard treatment protocol (ultrasonic scaling and chlorhexidine gluconate mouth wash) in the management of dental calculus.
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159
Efficacy and safety of
Guduchighana Vati
in asymptomatic and mild-to-moderate cases of coronavirus disease-19: A randomized controlled pilot study
Umesh Shukla, Nitin Ujjaliya, Pankaj Gupta, Vivek Khare, Babita Yadav, Amit Kumar Rai, Hetalben Amin, Rakesh Rana, Arunabh Tripathi, Shruti Khanduri, Bhagwan Sahay Sharma, Bhogavalli Chandrasekhararao, Narayanam Srikanth, Kartar Singh Dhiman
July-September 2020, 41(3):188-196
DOI
:10.4103/ayu.ayu_11_21
Background:
Currently, there is no approved treatment for the management of coronavirus disease (COVID-19). Drug repurposing of existing medications could be a possible way to find out a novel therapeutic entity to combat the COVID-19.
Aim:
To determine the clinical efficacy and safety of an Ayurveda intervention (
Guduchighana Vati
) in asymptomatic and mild-to-moderate cases of COVID-19.
Materials and methods:
This was an open-label randomized controlled pilot study with a sample size of 30 participants (15 in each arm). The participants were asymptomatic or mild to moderate cases of COVID-19.
Guduchighana Vati
500 mg twice daily for 10 days was administered in the study group and Hydroxychloroquine for 5 days in the control group. Paracetamol, Vitamin C, Multivitamin, and Zinc were also provided in the control group. The main outcome measures were to negative real-time reverse transcription–polymerase chain reaction (RT-PCR) assay for COVID-19, proportion of participants with negative RT-PCR for COVID-19 at 5
th
and 10
th
day, proportion of participants with clinical recovery, improvement in laboratory parameters, and incidence of adverse drug reaction/adverse event (ADR/AE). The results of RT-PCR and clinical recovery were compared between groups using Chi-square test. The data related to laboratory parameters were compared within group using paired sample
t
-test/Wilcoxon signed-rank test and between groups using independent sample
t
-test/Mann–Whitney test.
Results:
The proportion of participants with negative RT-PCR for COVID-19 in the
Guduchighana Vati
group (93.3%) was better as compared to the control group (66.6%) till 10
th
day of the study period. Though, the results are statistically not significant (
P
= 0.068). All the symptomatic patients in the
Guduchighana Vati
group clinically recovered whereas one patient remained symptomatic in the control group on the 5
th
day. No symptoms of COVID-19 were observed at 10
th
day in both the groups. No ADR/serious adverse event were observed during the study period in either of the groups.
Conclusion:
In this study on asymptomatic and mild to moderate cases of COVID-19,
Guduchighana Vati showed
numerically better proportion of participants with negative RT-PCR assay for COVID-19 and reduced time to clinical improvement which requires confirmation through studies with larger sample size. Although, the study outcomes are statistically not significant which may be due to small sample size.
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ORIGINAL ARTICLES - PHARMACEUTICAL STUDIES
Comparative pharmaceutico-analytical study of
Rasamanikya
prepared by two different
Shodhana
media of
Haratala
(orpiment)
Dipali Parekh, Sarika Makwana, Prashant Bedarkar, Biswajyoti Patgiri
July-September 2020, 41(3):197-207
DOI
:10.4103/ayu.AYU_261_19
Introduction:
Foremost,
Rasamanikya
is described in Rasendra Chintamani by Acharya Dhundhuknath. It is a formulation that is prepared from the arsenical drug, i.e., orpiment (
Haratala
).
Haratala
is classified under
Uparasa Varga
in
Rasa
classics and is also included under Schedule E1 in D and C act 1940. In classics, there are so many media mentioned for purification process (
Shodhana
) of orpiment. In the present study,
Kushmanda Swarasa
(juice of
Benincasa hispida
[Thunb.] Cogn) and
Churnodaka
(lime water) are adopted as the purification media for orpiment.
Aim:
The aim of this study was to standardize the pharmaceutical procedure of
Rasamanikya
and develop a comparative analytical profile of both the formulation, i.e.,
Rasamanikya
prepared by
Kushmanda Swarasa
and
Churnodaka Shodhita Haratala
.
Materials and methods:
The study was carried out in two stages as follows:
Shodhana
of
Haratala
and preparation of
Rasamanikya
by
Kupipakwa
method. Both the samples of
Rasamanikya
were analyzed for organoleptic and physicochemical parameters. The samples of final products were also analyzed through sophisticated analytical parameters, i.e., X-ray diffraction (XRD), Inductively coupled plasma-atomic emission spectroscopy (ICP-AES), CHNS and O, Field emission gun-scanning electron microscopy (FEG-SEM), Fourier transform infrared spectroscopy (FTIR) and Thermo-gravimetric analysis (TGA).
Results:
Average 2 h duration was required for the preparation of
Rasamanikya
formulation from 600 g of purified orpiment. In XRD analysis, both samples have different diffraction patterns. In ICP-AES analysis, both samples have the same percentage of arsenic. More percentage loss was noted in the TGA of
Rasamanikya
prepared with C
hurnodaka Shodhita Haratala
than that of
Kushmanda Swarasa Shodhita Haratala
.
Conclusion:
Rasamanikya
prepared by two different media of
Shodhita Haratala
did not found to have a substantial difference in pharmaceutical procedure. However, there was a considerable difference in the analytical study.
Kupipakwa
procedure can be used for large-scale preparation.
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1,019
128
REVIEW ARTICLE - REVIEW STUDY
Azadirachta indica
A. juss,
Morinda citrifolia
L. and
Triphala
as herbal endodontic irrigants: A scoping review
Archna Agnihotri, Swaty Jhamb, Urvashi Shrama, Sumidha Rohtagi
July-September 2020, 41(3):148-158
DOI
:10.4103/ayu.AYU_102_20
Background:
The success of the root canal treatment depends on the complete elimination of the microflora, biofilms and smear layer from the pulp space. A wide variety of chemical endodontic irrigants are available to achieve disinfection and thorough debridement besides mechanical means. However, detrimental properties such as allergic potential, cytotoxicity, antimicrobial resistance and safety concerns have intrigued researchers over the years to look for safer options.
Aim:
The review is aimed at providing comprehensive information of the studies evaluating the efficacy of
Azadirachta indica
A. juss (
A. indica
),
Morinda citrifolia
L. (
M. citrifolia
) and
Triphala
(fruits of
Emblica officinalis
Gaertn.,
Terminalia chebula
(Gaertn.) Roxb. and
Terminalia belerica
Retz.) as herbal endodontic irrigants.
Materials and methods:
The literature review was conducted using indexed databases (PubMed, Google Scholar, Cochrane) electronically for publications in peer-reviewed journals for relevant articles evaluating the efficacy of
A. indica, Triphala, M. citrifolia
as endodontic irrigant from the year 1985-March 2020.
Results:
A total of 58 studies were identified for full text reviewing after duplicate removal and screening title and abstracts. A total of 32 studies were included and processed for data extractions.
Conclusion:
Various in-vitro/in-vivo studies utilizing these herbal irrigants have documented promising results and hold the potential to replace chemical endodontic irrigants in routine practice but more preclinical and clinical trials are needed to substantiate these results before they can conclusively be recommended as intracanal irrigating solutions.
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338
INVITED ARTICLE
Overview of
Ayurveda
trials registered with Clinical Trial Registry-India: Need for customized data set items
Tulsi Adhikari, M Vishnu Vardhana Rao, Narayanam Srikanth, Atul Juneja, Saurabh Sharma, Mohua Maulik, Jyotsna Gupta, Yashmin Panchal, BC Rao, Shruti Khanduri, Rakesh V Narayan, Richa Bhardwaj, Prakriti Batra
July-September 2020, 41(3):143-147
DOI
:10.4103/ayu.ayu_375_21
Background:
Lack of research data is one of the major challenges identified in traditional medicine (TM). Further, there is an urgent need to strengthen and streamline clinical research processes as well as develop research databases in TM. The Clinical Trials Registry-India (CTRI), a free, online primary register of the WHO's International Clinical Trials Registry Platform, undertakes registration of all clinical trials being conducted in India, including TM trials. However, as the CTRI data set items are primarily designed to capture information of interventional trials of the conventional system of medicine, key fields relevant to the TM system are not adequately captured in the CTRI.
Aims and Objectives:
The current study was conceptualized with the objective to review the type and quality of trials registered in the CTRI as well as identify the specific data set items in CTRI which may be customized as per
Ayurveda
studies.
Materials and methods:
The trials registered from July 1, 2018, to March 31, 2020, were analyzed to decipher the kind of research being undertaken in the field of
Ayurveda
. These trials were manually reviewed independently by two
Ayurveda
reviewers to gain insights into the discrepancies. Along with these analysis, brainstorming sessions with Ayurveda experts were also held.
Results:
The fields which were identified and need tweaking and customization were the fields “health condition” and “intervention/comparator agent.”
Conclusions:
These modifications in the CTRI would enable the capture of more effective
Ayurveda
-specific information which would in turn help to standardize and streamline research practices as well as raise the standard of research.
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ORIGINAL ARTICLES - CLINICAL RESEARCH
Efficacy of
Virechana, Triphaladi
decoction with processed
Guggulu
in the management of ovarian cyst - A pilot study
Matangee Pandya, Shilpa B Donga, LP Dei, Anup B Thakar
July-September 2020, 41(3):166-172
DOI
:10.4103/ayu.AYU_254_19
Background:
Ovarian cyst is an emerging problem among the women of reproductive age group. Most of the ovarian cyst (80%–85%) are benign, and two-thirds of these occur in women between 20 and 44 years of age. They may be identified in asymptomatic women during routine pelvic examination or may produce symptoms. Management of the ovarian cyst through surgery is available to meet urgent need of the patient, but to establish a satisfactory conservatory medical treatment is the need of the hour. According to Ayurveda, ovarian cysts can be managed on the line of
Kaphaja Granthi
(nodular/glandular swellings by
Kapha Dosha
) and
Vidradhi
(abscess).
Aim:
The aim of this study was to evaluate the clinical efficacy of
Virechana
(therapeutic purgation),
Triphaladi Kashaya
(decoction) with processed
Guggulu
(
Commiphora mukul
Engl.) in the management of ovarian cyst.
Materials and methods:
16 patients were included in this clinical study and among them, 15 patients completed the treatment and one patient was dropped out from the trial. Patients were given
Virechana
followed by
Triphaladi Kashaya
(50 ml) with processed
Guggulu
(1 g) orally twice a day before meal for 60 days. The patients were followed up till 1 month. The assessment was carried out on subjective parameters such as lower abdominal pain, backache, and dysmenorrhea as well as objective parameters such as ovarian cyst size and volume by four-dimensional gray scale and color doppler sonography. Cancer antigen 125 was also assessed before and after treatment. Results were statistically analyzed using Wilcoxon signed-rank test and Student's
t
-test by sigma statistical tool (version 3.5, Systat Software Inc., United States).
Results:
Significant results were observed in subjective parameters such as lower abdominal pain (93.11%), backache (81.81) and dysmenorrhea (90.90%) as well as objective parameters such as reduction in size of the cyst (60%) and complete resolution of the cyst (26.66%).
Conclusion:
Triphaladi Kashaya
with processed
Guggulu
is more effective in hemorrhagic cyst and simple cyst rather than other cyst, due to
Shothahara
properties which may have effectively curtailed the progress of ovarian cyst.
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241
Efficacy of
Vyoshadi Guggulu
and
Shadushana Churna
in the management of subclinical hypothyroidism: An open labelled randomized comparative pilot clinical trial
Vidhya Bharti Sharma, Bharatkumar Chhaganbhai Padhar, Hari Mohan Lal Meena, Sandeep K Mathur
July-September 2020, 41(3):181-187
DOI
:10.4103/ayu.ayu_359_20
Background:
Subclinical hypothyroidism (SCH) is defined as a mildly reduced function of the thyroid gland having elevated serum thyroid-stimulating hormone (TSH) level and normal concentrations of free tri-iodothyronine (FT3), free tetra-iodothyronine (FT4), T3 and T4. It occurs due to
“Agnimandya”
(low metabolic activity) at the systemic and cellular level.
Vyoshadi Guggulu
and
Shadushana Churna
having its effect on
Agni
(a root cause of SCH) are expected to prevent overt hypothyroidism and revert subclinical stage to euthyroid.
Aim:
This study was planned to evaluate and compare the efficacy of
Vyoshadi Guggulu
and
Shadushana Churna
in the management of
Dhatvagnimandya
with special reference to sub-clinical hypothyroidism (SCH).
Materials and methods:
Patients having serum TSH levels between 5 and 10 mlU/L and normal T3 and T4 values were diagnosed as SCH. A total of 30 patients were registered and randomly divided into two groups. In group A, patients were treated with
Vyoshadi Guggulu
(6 g), while in group B with
Shadushana Churna
(3 g) twice a day after lunch and dinner for 60 days. The assessment was done through changes in baseline and after treatment values of serum TSH level. Outcomes of the trial were analyzed using SigmaStat 4.0 version (trial) software. Student's paired
t
-test was used for within-group assessment, while unpaired
t-
test was used for intergroup comparison of the normally distributed parametric data.
Observations and Results:
Ten patients in group A and 11 in group B could complete the course of treatment. The findings revealed that therapy in group A and B showed decrease of 16.61% (
P
= 0.0494) and 26.29% (
P
= 0.0140) in serum TSH, respectively, 1.80% (
P
= 0.025) and 1.36% (
P
= 0.019) decrease in body mass index (BMI), respectively. The decrease in TSH and BMI was statistically significant in each group. In comparison, the decrease in serum TSH (
P
= 0.384) and BMI (
P
= 0.677) was statistically insignificant.
Conclusions:
Vyoshadi Guggulu
and
Shadushana Churna
are statistically equally effective to reduce serum TSH and BMI in the management of SCH.
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© AYU (An International Quarterly Journal of Research in Ayurveda) | Official publication of Institute For Post Graduate Teaching & Research in Ayurveda,Jamnagar | Published by Wolters Kluwer -
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Online since 1st Aug, 2010