Clinical study of standardized shalmali ghrita wsr to Shweta Pradar (leucorrhoea)

Phase 4

Not yet recruiting

• Conditions: Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: Shweta paradar,

• Registration Number: CTRI/2023/05/052248
• Lead Sponsor: Shubhdeep ayurved medical college

Brief Summary

NEED OF STUDY

All women have experienced some short of vaginal discharge in her life span. With white vaginal discharge along with the other symptoms like feeling of weakness, pain in the back and calves, less of vital fluids, purities on and around the vulva, thighs and thigh joints etc. which comes under the heading of leucorrhoea, which is described as shweta pradara in Ayurvedic classics. Leucorrhoea is an annoying symptom in all ages of a woman. Leucorrhoea is not a disease but a symptom, however depending upon severity; many of female patients come in clinic with complaint of white discharge per vagina. In all classics Shweta pradara is mentioned as symptom of Yonivyapada3-4. However, depending upon the etiopathogenesis it appears to be vitiation of Kapha. Kapha aggravated due to its own vitiating factors influence Rasadhatu of reproductive system along with other causative factors such as too much coitus, improper mode of living etc produce excessive white vaginal discharge. The other factor is hormonal imbalance which affects physiological vaginal pH and causes excessive white vaginal discharge called as Leucorrhoea.

2.AIMS & OBJECTIVESOF THE STUDY: -

 Pharmaceutical preparation of Shalmali ghrita as per classical reference of Yogaratnakar [pradara chikitsa].

To carry out analytical study of Shalmali ghrita.

To study the clinical efficacy of Shalmali ghrita in non-specific Shweta pradara (Leucorrhoea)

4.DURATION OF THE STUDY:

Total Study Period   - Till completion of last enrolled patient.

Treatment Period     - 45 days

Follow up Period     - 15 days

(2)ANALYTICAL STUDY:

Analytical study of Shalmali ghrita will be carried out at recognized laboratory.

Assesment criteria:

1. Organoleptic characters

•Colour

•Odour

•Appearance

•Taste



2. Physico chemical parameters:

•Peroxide value

•Loss or drying at 1100C

•Refractive index

•Acid value

•Saponification value

•Iodine value

•Ester value

•Weight per ML

•Specific gravity

•TLC

12.INVESTIGATION DETAILS

•HB%

•TLC

• DLC

• ESR

SUBJECTIVE CRITERIA: Patient assessment will be carried out before, during and after the treatment,

•Srava (vaginal discharge)

•Daurvalya (feeling of weakness)

•Kandu (itching)

•Vedana (pain)

Daurgandhya

OBJECTIVE CRITERIA:

The objective criteria will be based on following investigation values obtained before and after treatment.

•HB%

•TLC

•DLC

•ESR

•Urine (Routine and Microscopic)

•Vaginal smear (as per requirement)

REFERENCES:

1. Murthy K.R.S.  Sharangdhar Samhita Publication Chaukhamba orientalia 2009 Page No.115

2. Shastri Bramhanand Shankar Yogratnakar Publication Choukhamba sannskrit samsthan 2004 page no.400

3. Shastri Kashinath chaturvedi Goraknath Charak Samhita volume2nd Chikitsa Sthana – Choukhamba Sanskrit Samsthan Varanasi 2001 page no.-842.

4. Shastri Ambikadatt  Sushruta samhita  volume 2nd .Publication – Choukhamba Sanskrit Samsthan , Varanasi 2001 Page  No 206 .

5. Shastri Bramhanand Shankar Yogratnakar Publication Choukhamba Sanskrit samsthan  Varanasi  2004 ,page  no. 396.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-05
• Study Start: 2023-05-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• (1) Female patients of age between 20 to 50 years.
• (2)Non-specific leucorrhoea.

Exclusion Criteria

• (1) Abnormal uterine bleeding.
• (2)Local gynaecological causes like ovarian cyst, prolapsed uterus, cervicitis, carcinoma, fibromyoma and polyps.
• (3)Systemic disease including diabetes mellitus, anemia, HIV and others.
• (4)Patients with STD.
• (5)Lactating mother.
• (6)Pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Srava (vaginal discharge)	4 week
•Daurvalya (feeling of weakness)	4 week
•Kandu (itching)	4 week
•Vedana (pain)	4 week

Trial Locations

Locations (1)

Shubhdeep ayurved medical college indorre; 🇮🇳 Indore, MADHYA PRADESH, India

Shubhdeep ayurved medical college indorre

🇮🇳Indore, MADHYA PRADESH, India

Dr suman dubey

Principal investigator

7470631658

Sumantiwari1046@gmail.com