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临床试验/CTRI/2022/07/044243
CTRI/2022/07/044243尚未招募不适用

A Clinical Assessment to evaluate the Efficacy of Yashtyadi Kwath and Shunthyadi Pindi in the Management of Praklinna Vartma with special reference to Squamous Blepharitis

Dr Akash Pralhad Gaikwad1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年7月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Reduction in the symptoms like Itching, burning, lacrimation, scale formation, congestion & swelling of eyelids

研究概览

简要总结

TITLE OF DISSERTATION

A CLINICAL ASSESSMENT TO EVALUATE THE EFFICACY OF YASHTYADI KWATH AND SHUNTHYADI PINDI IN THE MANAGEMENT OF PRAKLINNA VARTMA WITH SPECIAL REFERENCE TO SQUAMOUS BLEPHARITIS

**Aim:**To evaluate the efficacy of Yashtyadikwath and ShunthyadiPindi in Praklinnavartma w.s.r to Squamous Blepahritis.

Objectives:

  1. To study the etiopathogenesis of Praklinnavartma- Squamous Blepharitits from ayurvedic & modern point of view.

  2. To study the effectiveness of YashtyadiKwath and ShunthyadiPindi in Praklinnavartmaw.s.r. to Squamous Blepahritis at both local and systemic levels.

  3. To review the relevant literature on Praklinnavartma& Squamous Blepharitits in both Ayurveda & modern perspective.

HYPOTHESIS :-

  1. Null Hypothesis H0 :-

There is no effect of Yashtyadi kwath and Shunthyadi Pindi in the management of Praklinnavartma w.s.r. to Squamous Blepahritis.

  1. Research Hypothesis H1 :-

There is a significant effect of Yashtyadi kwath and Shunthyadi Pindi in the management of Praklinnavartma w.s.r. to Squamous Blepharitis.

MATERIAL AND METHODS:

•      Source of data

§   Patient fulfilling the criteria of inclusion will be screened and selected from OPD and IPD of Shalakya Tantra department of D Y Patil School of Ayurveda, Nerul, Navi Mumbai.

§  Method of collection of data

§  Patients of either sex will be selected based on symptoms of  Praklinnavartma w.s.r. to Squamous Blepharitis

§  Patient willing to participate in the present trial through written informed consent.

Diagnosis will be established on the basis of presence of following signs and symptoms.

1.         Itching in eyes

2.        Burning sensation in eyes

3.       Pain in eyes

4.        Swelling in eyelids

5.         Lacrimation (Watering from eyes).

6.        Dandruff like deposition (Scales) on eye lid margin.

7.        Through Slit lamp examination - Presence of Scaling on lid margins, Congestion, Oedema of Eyelids.

1) Inclusive criteria -

  1. Patients presenting with the clinical features of Praklinnavartma (Squamous Blepharitis)

2. Patient with in the age group between 18 to 60 years

3. Patients who are willing to undergo the respective treatment protocol.

2) Exclusive criteria -

1.Patients who are below 18 years and above 60 years are excluded.

2.Pregnant women and lactating mother.

3.Patients suffering from other systemic disease like Hypertension, Diabetes Mellitus, Tuberculosis and Asthma.Associated with psoriasis and other skin diseases.

4.Patients suffering from other ocular disorders like Ptosis, Corneal ulcers, Follicular conjunctivitis, Purulent Conjunctivitis, Trichiasis, Multiple styes,  Tumors etc.

PINDI KRIYAKALPA :-

v  Kriyakalpa are basically the procedures that are described where medicated Ghee and Churna (powdered formulations) or paste made from churna are administered either directly or indirectly (above or around) the eyes as an effective treatment modality.

v  Pindi is one of the Kriyakalpa described in Sharangdhar Samhita along with Bidalak in addition to other Kriyakalpas viz. Tarpan, Putapaka, Seka, Anjan and Ashchyotan.

v  Pindi is modification of bidalak. in this paste of medicines are covered in a cloth are placed over the closed eyes. it is also called as ‘kavalika’.

CONTENT**:-**

NAME

QUANTITY

FORM

|Shunthi

2gm

Churna

|Nimbapatra

2gm

Churna

|Saindhav

1 pinch

Churna

SOP of preparation of Shunthyadi LepaPindi:-

  1. Mix all these drugs with addition of water and cook this mixture till it get thick and attain paste (Kalka) like consistency.

  2. Then place a clean cloth over both eyes and put the lukewarm paste (3-4gm) over the cloth.

  3. Put this for 15-20 mins over the eyes.

RAS PANCHAKA:-

DRUG

LATIN NAME

RASA

VIRYA

VIPAK

GUNA

KARMA

| Shunthi

 Zingiber officinale

 Katu

 Ushna

 Madhura

 Snigdha, Laghu

Vrishya, Sopha-Kapharuchihara, Vatodara, Swasa, Pandu, SlipadaNasini

| Nimba

 Azadirachta indica

 Tikta, Kashaya

 Sheeta

 Katu

 Ruksha, Laghu

Vranahar, Kushtahara

| Sainshav

 Rock salt

Lavana

 YASHTYADI KWATH :-

Steps Of Preparation OF YASHTYADI KWATH :-

ü  Mix all the churna of the following drugs viz. Yashtimadhu, Guduchi, Triphala and Daruharidra in equal quantity.

ü  Prepare a Decoction (Kwath) of these drugs for internal administration.

ü  Drugs which are used are of Rasayana, Tridoshashamak, Netrarogahar, Kandughna, Vedansthapan properties.

Content :-

Name

Quantity

Form

|Yashtimadhu

2gm

Churna

|Guduchi

2gm

Churna

|Triphala

2gm

Churna

|Daruharidra

2gm

Churna

  RAS PANCHAKA:

DRUG

LATIN NAME

RASA

VIRYA

VIPAK

GUNA

KARMA

| Yashtimadhu

 Glycyrrhiza glabra

 Madhura

 Sheeta

 Madhura

 Guru, Snigdha

Sandhaneeya, Varnya, Kandughna, Shonitasthapana

| Guduchi

 Tinospora cordifolia

 Kashaya, Tikta

 Ushna

 Madhura

 Laghu, Snigdha

Balya, Dahahara, Kushthahara, Krimihara, Chakshushya

| Triphala

Terminalia chebula

Terminalia bellerica

Emblica officinalis

 Madhura, Amla, Katu, Tikta, Kashaya

Ushna

Madhura

Ruksha

Sara

Chakshushya, Deepana, Varnaropana, Ruchikara, Medohara

| Daruharidra

 Berberis aristata

 Kashaya, Tikta

 Ushna

 Katu

 Laghu, Ruksha

Arshaghna, Lekshaniya, Kandughna

 ASSESMENT CRITERIA :-

•      An assessment criteria is designed based on subjective parameters :-

1.      Itching of eyelids (Kandu)

2.      Burning sensation (Daha)

3.      Lacrimation (Strav

4.      Scaling on Lid margin (Klinnata)

5.      Congestion of lid margin (Raga)

6.      Lid margin Oedema (Shotha)

 1) Itching of eyelids (Kandu) :-

 0

 Absent

 No Itching

| 1

 Mild

 Occassional itching sensation

| 2

 Moderate

 Intermittent itching sensation which requires rubbing of eye

  | 3

 Severe

Most of the time intolerable itching which would requiresignificant eye rubbing

 2)      Burning sensation (Daha) :-

 

 0

 Absent

 No burning sensation

  | 1

 Mild

 Occasional burning sensation

  | 2

 Moderate

 Intermittent burning sensation

  | 3

 Severe

Most of the time burning sensation

 3)      Lacrimation (Strav) :-

 0

 Absent

 No lacrimation

  | 1

 Mild

 Occasionally, tear flow out of eyes

  |  2

  Moderate

 Intermittent out flow of tears 4-5 times / day on exposure to wind or doing some work

  | 3

 Severe

 Most of the time out flow of tears is present

 4)      Scales formation (Klinnata) :-

 0

 Absent

 No Scales formation

  | 1

 Mild

 Small quantity of Whitish material on lid margins

  |  2

  Moderate

 Moderate quantity of whitish material on lid margins

  | 3

 Severe

 Whitish material lead to sticking of the eyelid margins.

 5)      Congestion of lid margin :-

 0

 Absent

 No Congestion

  | 1

 Mild

 Congestion, visible on slit lamp examination

  |  2

  Moderate

 Congestion, visible on torch light examination

  | 3

 Severe

 Congestion, visibly evident ondirect inspection

 6)      Lid Margin oedema (Shopha) :-

 0

 Absent

 No lid margin           oedema

  | 1

 Mild

 Lid margin oedema visible on slit lamp examination

  |  2

  Moderate

 Lid margin oedema visible on torch light examination

  | 3

 Severe

 Lid margin oedema visibly evident on direct inspection

TREATMENT PROTOCOL :-

SAMPLE SIZE

                         50 PATIENTS

  | TREATMENT DAYS

  45 DAYS

  | PINDI KRIYAKALPA DAYS

  DAILY FOR 7 DAYS THEN TWICE A WEEK

  | KAAL OF THE KRIYAKALPA

  IN THE MORNING

  | KWATH

 YASHTYADI KWATH

  | DOSE OF THE KWATH

  30ML

| KAAL OF THE KWATH

  TWICE A DAY BHOJANOTTAR

 BIBLIOGRAPHY:

1.The Chaukhamba Ayurvijnan Granthamala 71, Sushruta Samhita of Maharshi Sushruta Volume III Edited with ‘Susrutavimarsini’ Hindi Commentary Along with Special Deliberation by Dr. Anant Ram Sharma Foreword by Acharya Priya Vrat Sharma.

2.Krishnadas Ayurveda Series Vol. 27, Vagbhata’sAstangHridayam Translated by Prof. K. R. Srikantha Murthy Volume III UttarSthana.

3.Krishnadas Ayurveda Series 54, Yogaratnakar with ‘Vaidyaprabha’ Hindi commentary by Dr. Indradev Tripathi and Dr. Dayashankar Tripathi.

4.Jaikrishnadas Ayurveda Series No. 58 Sarangdhar Samhita (A treatise on Ayurveda) By Sarangdhar, Translated in English by Ayurvedvidwan Prof. K.R. Srikantha Murthy.

5.Kashi Ayurveda Series 17, Cakradatta (Sanskrit text with English translation), A treatise on Principles and Practices of Ayurvedic Medicine, Edited and Translated by Priya Vrat Sharma.

6.The Chaukhamba Ayurvijnan Granthamala 80, BhaisajyaRatnavali of KavirajGovindadas Sen Edited with ‘Siddhiprada’ Hindi Commentary by Prof. Siddhi Nandan Mishra.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients presenting with the clinical features of Praklinnavartma (Squamous Blepharitis) 2.Patient with in the age group between 18 to 60 years 3.Patients who are willing to undergo the respective treatment protocol.

排除标准

  • Patients who are below 18 years and above 60 years are excluded.
  • ï¶ Pregnant women and lactating mother.
  • ï¶ Patients suffering from other systemic disease like Hypertension, Diabetes Mellitus, Tuberculosis and Asthma.
  • ï¶ Associated with psoriasis and other skin diseases.
  • ï¶ Patients suffering from other ocular disorders like Ptosis, Corneal ulcers, Follicular conjunctivitis, Purulent Conjunctivitis, Trichiasis, Multiple styes, Tumors etc.

结局指标

主要结局

Reduction in the symptoms like Itching, burning, lacrimation, scale formation, congestion & swelling of eyelids

时间窗: 7 weeks

次要结局

未报告次要终点

研究者

发起方
Dr Akash Pralhad Gaikwad
申办方类型
Other [self]

研究点 (1)

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