Randomised Controlled Clinical Trial Of Add-on Effect Of Vardhaman Pippali Rasayana On Vidangadi Loha In Management Of Pandu.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Improvement in PANDUTA, DOURBALYA, SHIRASHOOLA, SHWAS ,HRIDSPANDAN, ARUCHI, AKSHIKOOTA, SHOTH, PINDIKODWESHTAN, BHRAMA, RUKSHATA, GAURAVA, SHRAMA, Hb% ,RBC, MCV, MCH, MCHC and TIBC
Study Overview
Brief Summary
One of the specialities of Ayurvedais the rasayana karma mentioned in it. Diseases like Pandu are not only causedby some dietary causes but it is majorly impacted by the person’s nutritionhence while treating Pandu, only the disease curing (Vyadhi pratyanik chikitsa)strategy does not help but supplemental help (Rasayana Chikitsa) to prolong itseffect is also very much necessary. Hence here in case of Pandu Vidangadi lohacan be used to treat the basic cause of the disease but to get better resultsin the management of the disease subject will be given supplemental meaningRasayan vidhi to prolong its effect. And Pippali’s rasayana karma can bestudied through this in Pandu. Vardhaman Pippali Rasayana is explained bySharangdhar in his texts in Madhyam khanda, as useful in treating Pandu Vyadhiby its Rasayana, Deepana & Pachana, Raktvardhak, Raktashodhak property. Itis also mentioned in Charak Samhita for the same. Hence, this is an attempt toevaluate the efficacy of Vardhaman Pippali Rasayana on the basis of subjectiveand objective parameters.
women of age group of 15 to 49 years. Intervention drug is administered with primary outcome of improvement in clinical signs and symptoms of Pandu andimprovements in laboratory parameters and changes in quality of life as secondary outcome. Assesments aredone at baseline and after 21 days of treatment and patients are followed up for a period of 1 months aftercompletion of treatment for any recurrence of the signs and symptoms. As per the study protocol sufficientnumber of subjects has been registered and recruitment is complete.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 15.00 Year(s) to 49.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •The presence of symptoms of Pandu as described in classical Ayurvedic texts such as Panduta, Dourbalya, Shirshoola, Shwasa, Hridaspandan, Aruchi, Akshi koota shotha, Pindikoudveshthan, Bhrama, Rukshata, Gourava and Shrama.
- •Women of reproductive age group of 15-49 years 3)Patients having history of Hb% <12 g% (Female) , low mean corpuscular volume (MCV) (<80 fl); serum iron <50 µg/dl, total iron binding capacity (TIBC) >360 µg/dl.
Exclusion Criteria
- •Patients having history of Haemoglobin <7 gm% 2)Patients suffering from haematological disorders such as sickle-cell anaemia and thalassemia are excluded.
- •Patients having history of systemic disorders such as uncontrolled hypertension, uncontrolled diabetes mellitus, AIDS, and cancer.
- •Pregnant females and lactating mothers.
- •Gynaecological diseases like Menorrhagia and Obstetric disorders leading to blood loss 6)Grishma and Sharad Ritu.
Outcomes
Primary Outcomes
Improvement in PANDUTA, DOURBALYA, SHIRASHOOLA, SHWAS ,HRIDSPANDAN, ARUCHI, AKSHIKOOTA, SHOTH, PINDIKODWESHTAN, BHRAMA, RUKSHATA, GAURAVA, SHRAMA, Hb% ,RBC, MCV, MCH, MCHC and TIBC
Time Frame: baseline,10th day, 21st day
Secondary Outcomes
- to study the adverse effects of Vardhaman Pippali rasayan, if any(21 days)