| CTRI Number |
CTRI/2023/05/052248 [Registered on: 03/05/2023] Trial Registered Prospectively |
| Last Modified On: |
02/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study of standardized shalmali ghrita wsr to Shweta Pradar (leucorrhoea) |
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Scientific Title of Study
|
Pharmaceutical analytical and clinical study of shalmali ghrita w.s.r. to Shweta pradara(leucorrhoea) |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr suman dubey |
| Designation |
Post graduation scholar |
| Affiliation |
Shubhdeep ayurved medical college Datoda Indore MP |
| Address |
Shubhdeep ayurved medical college Datoda Indore
Indore
MADHYA PRADESH
452020
India |
| Phone |
7470631658 |
| Fax |
|
| Email |
Sumantiwari1046@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAkhilesh shrivastava |
| Designation |
Professor |
| Affiliation |
Shubhdeep ayurved medical college Datoda,Indore (M.P.) |
| Address |
Shubhdeep ayurved medical college Datoda Indore mp
Indore
MADHYA PRADESH
452020
India |
| Phone |
9993281713 |
| Fax |
|
| Email |
drshrivastava.akhilesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAkhilesh shrivastava |
| Designation |
Professor |
| Affiliation |
Shubhdeep ayurved medical college Datoda,Indore (M.P.) |
| Address |
Shubhdeep ayurved medical college Datoda Indore mp
Indore
MADHYA PRADESH
452020
India |
| Phone |
9993281713 |
| Fax |
|
| Email |
drshrivastava.akhilesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shubhdeep ayurved medical college and hospital gram dataoda khandwa road indore 452020 |
|
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Primary Sponsor
|
| Name |
Shubhdeep ayurved medical college |
| Address |
Shubhdeep ayurved medical college Datoda Indore |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr suman dubey |
Shubhdeep ayurved medical college indorre |
Room no G 13 Dpet Of RSBK -Shubhdeep ayurved medical college Datoda Indore 452020
Indore
MADHYA PRADESH |
7470631658
Sumantiwari1046@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comitttee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: Shweta paradar, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shalmali ghrita, Reference: Yogratnakar stri rog1-2, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
(1) Female patients of age between 20 to 50 years.
(2) Non-specific leucorrhoea.
|
|
| ExclusionCriteria |
| Details |
(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
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
• Srava (vaginal discharge)
• Daurvalya (feeling of weakness)
• Kandu (itching)
• Vedana (pain)
|
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/05/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Sumantiwari1046@gmail.com].
- For how long will this data be available start date provided 05-11-2023 and end date provided 05-11-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
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Brief Summary
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 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.
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