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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: dryesane@rediffmail.com

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.

REFERENCES:

[1] Dr.Indradev Tripathi: Chakradatta, ;Chaukambha

Sanskrit Sansthan, Varanasi; Reprint Edition,

2005

[2] Acharya Siddhinandan Mishra; Bhaishajya

Kalpana Vignan: Chaukambha Surbharati

Publication, Varanasi Reprint Edition, 2002.

[3] Kaviraj Sri Ambikadattashastri Ayurvedacharya:

Bhaishajyaratnavali: Chaukambha Sanskrit

Sansthan, Varanasi; 14th Reprint Edition, 2011.

[4] Prof. Yadunandan Upadhaya: Madhavnidan II of

Sri Madhavkara: Chaukambha Sanskrit Sansthan,

Varanasi : 29th Edition : 2000.

[5] Vd Yadavji Trikamji Acharya: Sushruta Samhita of

Dallhanacharya: Chaukambha Orientalia,

Varanasi: 2009.

[6] Vd Yadavji Trikamji Acharya: Sushruta Samhita of

Dallhanacharya: Chaukambha Orientalia,

Varanasi: 2009.

[7] Dr.Indradev Tripathi: Chakradatta, ; Chaukambha

Sanskrit Sansthan,Varanasi; Reprint Edition,2005

[8] Acharya Priyavratsharma; Dravyaguna Vignan

Part-II; Chaukambha Bharati Akadami, Varanasi;

2006

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.

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