ADJIM, July - Sept 2019; Vol. 4 Issue 3 ISSN(Online): 2455-9989
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Ayurved Darpan
Journal of Indian Medicine An International Quarterly Publishing Peer Reviewed Journal
Pharmaceutico-analytical study of Tiladi Lepa w.s.r. to clinical study on
Bhagandara
Associate Professor, Department of Rasashastra & Bhaishajya Kalpana
Sudhir K. Yesane*
L. K. R. Ayurved College and P. G. Training Centre, Gadhinglaj, Maharashtra, India - 416502
Research Article
ABSTRACT:
Tiladi lepa is described by Chakra Datta which contains Tila, Haritaki, Lodhra twaka and Nimda patra in equal
quantity.[1] In this study the Tiladi lepa was prepared according to Lepa kalpana [2]. The kalpa was standardized
on Pharmaceutical and Analytical parameters and then used in clinical study for Bhagandara roga. [3] The study
shown that the raw materials were of approved quality. The analytical study shown that the ingredients and
prepared Tiladi lepa of present study reach the standards. The clinical study given the satisfactory results on
Bhagandara Roga.
Bhaishajya Kalpana gifts many methods of
preparation of Aushadhis for Ayurveda. The classical
methods of preparation of Aushadhi are standard. The
Tiladi lepa is prepared according to classical
references to assess the standards in Pharmaceutical
part. The analytical study of the raw materials and
prepared drug is done. The prepared Kalpa is
subjected for clinical efficacy on Bhagandara, which
shown satisfactory results.
Aim:
To prepare the Tiladi Lepa and to carry analytical
study for standardization. Also to carry the clinical
study for Bhagandara Roga.
Objectives: The objectives of present study are-
a) Assessment of standardization of Tiladi Lepa by
standard selection and Preparation procedures
such as:
1. Procurement of Tila, Haritaki, Lodhra twaka and
Nimda patra from local market of expected
qualities only.
2. Tiladi Lepa was prepared as per ref. from
Bhaishajya Ratnavali. (Bhagandar rogadhikar
4/51)
b) Analytical study: This was included.
1. Organoleptic characteristics of Tila, Haritaki,
Lodhra twaka and Nimda patra and Tiladi lepa.
2. Physico- Chemical Analysis of Tiladi Lepa.
c) Clinical study of Tiladi Lepa on Bhagandara. This
included an open clinical trial on patients of
Bhagandara.
Ethical clearance:
This study is clinical study and required patients for
assessment purpose. Hence the ethical clearance was
taken from Institute Ethical Committee.
MATERIALS AND METHODS:
The present study was subjected to preparation and
physico- chemical analysis of Tildi lepa, clinical trial
on patients of Bhagandara. Following methods were
adopted in the intention to complete the research
work.
1. Collection of literature- The literature was
obtained from classical books on
Rasashastra, Bhaishajya kalpana and Ayurveda.
Also the modern books of pharmacy,
Pharmacology from the college library.
01
KEY WORDS: Tiladi lepa, Standardization, analysis, clinical study, Bhagandara
INTRODUCTION:
* Corresponding Author: Sudhir K. Yesane, E-mail: [email protected]
Article Received on: 16/09/2019 Accepted on: 27/09/2019 Published on: 30/09/2019
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2. Collection of raw materials and necessary
materials- The main ingrediants as Tila, Haritaki,
Lodhra twaka and Nimda patra were collected
from the local market as per the approved quality
stated in the classical texts. The necessary
materials and equipments were also collected
from local market and department.
3. Pharmaceutical study- Pharmaceutical work
was carried out at college and departmental
practical hall. The study included-
Selection of Ingredients.
Preparation of Tiladi Lepa.
4. All these practicals were carried according to
classical references.
5. Clinical study – The clinical study was carried at
L.K.R. Ayurved Hospital. This included –
A. Bhagadara-
Nidan: Aahar Vihar – Kashaya rasa sevana,Ruksha
anna,Asthi yukta aahar sevana, Truma by Krimi and
Asthi, Vasti netra vyapada, Papkarma. (4)
Saprapti: Due to Nidansevana the Vatadosha gets
vitiated in the Aamashaya. The vitiated Vata does
dushan of Mamsa and Rakta dhatu. These vitiated
dosh and dushya takes Sthansanshraya at Guda
Pradesh and produce Darana of Vasti, Guda and
Bhaga to cause Bhagandara.(5)
Laxana: (6)
1. Pain at Kati and Guda pradesha.
2. Daha at Guda pradesh.
3. Kandu at Guda pradesh.
4. Shoph at Guda pradesh.
5. Bhagandara Pidika.
6. Discharge
B. Inclusion criteria-
1. 30 Adult Patients of either sex.
2. Classical symptoms of Bhagandara.
3. Patients weight between 45 kg to 70 kg.
C. Exclusion criteria.
1. Menstruated and pregnant adult female
patients.
2. Patients of chronic debilitating associated
diseases like Cardiac disease, severe
uncontrolled DM, T.B, patients.
3. Under nourished patients.
Source of data
30 patients with classical symptoms of Bhagandara
were selected randomly from Shalya Tantra O.P.D of
L.K.R. Ayurvedic Hospital Gadhinglaj.
Method of Collection of Data
Patients who fulfilled the diagnosis and inclusion
criteria were selected for the study. Selected patients
were thoroughly examined; both objective and
subjective manifestations were recorded.
Informed consent from patients.
The present study includes a sample size of 30
patients in and around Gadhinglaj. All of them were
made to understand about the study and the
informed consent was obtained. Only after getting the
informed consent, they were included in the study.
Assessment criteria
1. Assessment was made by observing the
improvements in the clinical features based on
the gradation before and after the treatment.
2. Assessment was made on the following schedule
a. 1st assessment on the registration day.
b. 2nd assessment on 5th day, 3rd assessment on
10th day and finally 4th assessment on the last
day of treatment i.e. on 15th day.
3. Patients were assessed the following parameters
and the sign and symptoms were graded from 0
to 3 by the patients and examination done on
modified visual analogue scale.
Gradation of clinical features:
1. Pain at Kati and Guda pradesha.
Grade 3-Sever Pain at Kati and Guda pradesha.
Grade 2-Moderate Pain at Kati and Guda pradesha.
Grade 1-Mild Pain at Kati and Guda pradesha.
Grade 0-No Pain at Kati and Guda pradesha.
2. Daha at Guda pradesh.
Grade 3- Severe Daha at Guda pradesh.
Grade 2- Moderate Daha at Guda pradesh.
Grade 1- Mild Daha at Guda pradesh.
Grade 0- No Daha at Guda pradesh.
3. Kandu at Guda pradesh.
Grade 3- Severe Kandu at Guda pradesh.
Grade 2- Moderate Kandu at Guda pradesh.
Grade 1-Mild Kandu at Guda pradesh.
1 Grade 0- No Kandu at Guda pradesh.
4. Shoph at Guda pradesh
Grade 3- Severe Shoph at Guda pradesh
Grade 2- Moderate Shoph at Guda pradesh.
Grade 1- Mild Shoph at Guda pradesh
Grade 0- No Shoph at Guda pradesh.
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5. Bhagandara Pidika.
Grade 3- Severe Bhagandara Pidika.
Grade 2- Moderate Bhagandara Pidika.
Grade 1- Mild Bhagandara Pidika.
Grade 0- No Bhagandara Pidika.
6. Discharge.
Grade 3-Severe Discharge.
Grade 2-Moderate Discharge.
Grade 1-Mild Discharge.
Grade 0-No Discharge.
Overall assessment:
The overall assessment of the patient was made
based on the following criteria.
Absence of signs & symptoms - Cured
Reduction in the signs & symptoms- Improved
No change in signs & symptoms - No Improvement.
RESULTS:
The results of Pharmaceutical, Physico - chemical and
clinical studies are as follows-
Pharmaceutical studies.
The results of Pharmaceutical studies found during
this work were significantly similar to that of
practicals stated in reference books. Which are as
follows-
1. Selection of Ingredients -
2. Tila, - 800 gm.
3. Haritaki - 800 gm.
4. Lodhra twaka - 800 gm.
5. Nimda patra - 800 gm.
The above ingredients were procured from local
market with application of identification standards.
The authentification of ingredients was taken from
dept. of Dravyaguna, LKR. Ayu. College.
2. Tiladi lepa Nirman: (7)
Quantity of Tila - 800 gm
Quantity of Haritaki - 800 gm.
Quantity of Lodhra Twaka - 800 gm.
Quantity of Nimba Patra - 800 gm.
Quantity of Shudha Jala - Q.S.
Quantity of Prepared Tiladi Lepa - 3284 gm.
Gain in weight - 84 gm.
Consistency - Fine paste.
Colour - Dark greenish.
Time taken for practical - 1 day.
03
Table No. 1: Organoleptic characteristics of ingredients: (8)
Tila Haritaki Lodra Twaka Nimba Patra
Sanskrit Name Tila Haritaki Lodra Nimba
Latin Name Sesamum indicum Terminalia chebula Symplocos racemosa Azadirecta indica
Family Pedaliacede Combratecae Symplocaceae Meliaceae
Rasa Madhur Kashay, Madhur, Amla,
Katu, Tikta
Kashay Tikta, Kashay
Guna Guru, Snigdha Laghu, Ruksha Laghu, Ruksha Laghu
Colour Blackish Brown Brown Dark brown Green
Odor Faint Faint Faint Pungent
Touch Smooth Rough Rough Smooth
Table No. 2: Organoleptic characteristics of Tiladi Lepa
Characters Tiladi Lepa
Rasa Kashay, Tikta, Madhur
Guna Laghu, Ruksha
Colour Blackish Green
Odor Faint
Touch Smooth
Table No. 3: Analytical reports of Tiladi Lepa
Name of test Result
Loss on Drying 44.21
pH 5.2
Total Fat 7.1
Rancidity Not oxidized
Refractive index 1.116
Spreadability 782.64 g/cm/sec
HPTLC %
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On the study of the subject, apart from the literary
study, the research work was carried out. All the
findings are discussed here.
04
Table No. 4: Results of Clinical study of Tiladi Lepa on Bhagandara
The results of Experimental study were analyzed for
statistical significance on the basis of Paired ‘t’ test.
It was observed that the reduction in the complaints
was statistically non-significant up to the 2nd
assessment. Whereas the reduction in complaints were
statistically significant after 4th assessment.
Parameters 1st Assessment 2nd Assessment 3rd Assessment 4th Assessment
Pain at Kati and Guda
pradesha
Observed in all
patients.
Observed in all
patients.
Reduced in12
patients.
Reduced in 16
patients. Daha at Guda pradesh Observed in all
patients.
Observed in all
patients.
Reduced in 10
patients.
Reduced in 15
patients. Kandu at Guda pradesh Observed in all
patients
Observed in 24
patients
Reduced in 18
patients
Reduced in all
patients. Shoph at Guda pradesh Observed in all
patients.
Observed in 26
patients.
Reduced in 15
patients.
Reduced in 18
patients. Bhagandara Pidika Observed in all
patients.
Observed in all
patients.
Reduced in 8
patients.
Reduced in 11
patients. Discharge
Observed in all
patients.
Observed in all
patients.
Reduced in 24
patients.
Reduced in 24
patients.
Parameters Mean BT Mean after 4th
assessment
SD SE t value
Pain at Kati and Guda pradesha 2.56 1.4 0.98 0.18 6.44
Daha at Guda pradesh 2.66 1.46 1.55 0.28 4.39
Kandu at Guda pradesh 2.73 0.1 0 0 0
Shoph at Guda pradesh 2.73 1.26 0.68 0.12 12.16
Bhagandara Pidika 2.73 1.93 1.13 0.20 0.028
Discharge 2.73 0.96 0.93 0.17 10.35
P < 0.05
Table No. 5: Statistical Presentation of Experimental Study
Graph No. 1: Graphical representation of Experimental Study
DISCUSSION:
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1. Raw materials- Looking at the reports of
analysis study, it can be said that Tila, Haritaki,
Lodhra twaka and Nimda patra were of
acceptable quality.
2. Tiladi lepa Nirman- The preparation of Tiladi
lepa was done as per Lepa Kalpana method. The
pharmaceutical and analytical results show that
the preparation was of standard quality. Hence is
used for further clinical study.
3. Analytical study-
General analysis- The ingredients of prepared
Tiladi lepa are having appropriate organoleptic
characters. The Tiladi lepa has Loss on Drying as
44.21, the pH as 5.2, the Total Fat as 7.1, the
Refractive index as 1.116 and other analytical
values are competitive to standard value.
4. Clinical study- The clinical study carried at L.K.R.
ayurved Hospital. The patients were selected
from hospital Shalya Tantra O.P.D. The patients
were selected as per inclusion criteria. Among all
30 patients, 25 patients completed the study. The
patients were applied the Tiladi lepa at affected
site once daily.
Looking at the contents of Tiladi lepa and rasa, guna,
karma of contents of preparation it seems that the
drug is acting as Anti-inflammatory and Curative
property. Finally in the laxanas of Bhagandara it was
observed that the Pain at Kati and Guda pradesha is
reduced in 16 patients. The Daha at Guda pradesh
was reduced in 15 patients. Kandu at Guda Pradesh
reduced in all patients. The Shoph at Guda pradesh
was reduced in 18 patients. The Bhagandara Pidika
was reduced in 11 patients. The Discharge was
reduced in 24 patients. No any accountable side
effects were found in any patient of study.
The overall all assessment in the present study was as
follows-
The improvement was observed at 64 %.
It can be stated as the Tiladi Lepa may be used in
Bhagandara.
CONCLUSION:
The present study chiefly aimed at preparation of
Tiladi Lepa, its analytical study and clinical study.
From the total study the conclusion drawn is as
follows-
i. Raw materials used are known, authenticated
and uncontroversial.
ii. The prepared Tiladi lepa shown the Analytical
values comparative to standard values.
iii. The clinical study proved that the Tiladi Lepa can
be used in Bhagandara safely.
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Sanskrit Sansthan, Varanasi; Reprint Edition,
2005
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[4] Prof. Yadunandan Upadhaya: Madhavnidan II of
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Cite this article as:
Sudhir K. Yesane, Pharmaceutico-analytical study of
Tiladi Lepa w.s.r. to clinical study on Bhagandara,
ADJIM 2019: 4(3), p. 01-05.
05